Primsol

Shigellosis, Nocardiosis, Brucellosis + 16 more

Treatment

17 FDA approvals

16 Active Studies for Primsol

What is Primsol

Trimethoprim

The Generic name of this drug

Treatment Summary

Trimethoprim is a type of antibacterial medication used to prevent the growth of bacteria. It works by blocking the production of an enzyme called dihydrofolate reductase (DHFR), which stops bacteria from making an important building block for DNA. Trimethoprim is often used in combination with sulfamethoxazole, but can be used alone to treat or prevent urinary tract infections. It is related to another antifolate drug called pyrimethamine, which is used to treat infections caused by parasites.

Septra DS

is the brand name

image of different drug pills on a surface

Primsol Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Septra DS

Trimethoprim

1973

343

Approved as Treatment by the FDA

Trimethoprim, also called Septra DS, is approved by the FDA for 17 uses including Cholera and susceptible Enteritis infectious caused by Shigella sonnei .

Cholera

Used to treat susceptible Cholera in combination with Sulfamethoxazole

susceptible Enteritis infectious caused by Shigella sonnei

Used to treat susceptible Enteritis infectious caused by Shigella sonnei in combination with Sulfamethoxazole

Fluid replacement therapy

Used to treat Fluid replacement therapy in combination with Sulfamethoxazole

Urinary tract infection

Used to treat Urinary Tract Infection caused by susceptible bacteria in combination with Sulfamethoxazole

Nocardiosis

Used to treat Nocardiosis in combination with Sulfamethoxazole

Pneumonia, Pneumocystis

Used to treat Pneumocystis Jirovecii Pneumonia in combination with Sulfamethoxazole

Genus Pneumocystis

Used to treat risk of Pneumocystis jiroveci pneumonia (PCP) in combination with Sulfamethoxazole

Otitis Media

Used to treat Acute Otitis Media caused by susceptible bacteria in combination with Sulfamethoxazole

Brucellosis

Used to treat Brucellosis in combination with Rifampicin

Electrolyte replacement

Used to treat Electrolyte replacement in combination with Sulfamethoxazole

Pneumocystis Jirovecii Pneumonia

Used to treat Pneumocystis Jirovecii Pneumonia in combination with Sulfamethoxazole

Shigellosis

Used to treat Dysentery, Bacillary in combination with Sulfamethoxazole

Bronchitis

Used to treat Acute Exacerbation of Chronic Bronchitis (AECB) caused by susceptible bacteria in combination with Sulfamethoxazole

Diarrhea

Used to treat susceptible Travelers' Diarrhea caused by Enterotoxigenic E. Coli (ETEC) Infection in combination with Sulfamethoxazole

susceptible Enteritis infectious caused by Shigella flexneri

Used to treat susceptible Enteritis infectious caused by Shigella flexneri in combination with Sulfamethoxazole

Brucellosis

Used to treat Brucellosis in combination with Rifampicin

Immunocompromised

Used to treat Immunocompromised in combination with Sulfamethoxazole

Effectiveness

How Primsol Affects Patients

Trimethoprim prevents certain bacteria from making the proteins and acids they need to survive. It works mainly against gram-negative bacteria and some species of Staphylococcus. Bacteria can become resistant to trimethoprim, which means it may not work as well. Rarely, this drug can cause blood disorders like low platelets, low white blood cells, or sore throat with fever, pallor, or purpura. It's important to check the local antibiotic resistance patterns before using this drug.

How Primsol works in the body

Trimethoprim works to kill bacteria by blocking an enzyme that helps bacteria create proteins and nucleic acids. It has a stronger binding affinity to the bacterial enzyme than its mammalian counterpart, allowing it to selectively target bacteria. When taken alone, it can stop bacteria from reproducing, but when taken in combination with sulfamethoxazole, it stops two consecutive steps in the bacteria's protein and nucleic acid creation, resulting in the bacteria's death.

When to interrupt dosage

The measure of Primsol is contingent upon the manifested affliction, including Urinary tract infection, Immunocompromised and Pneumocystis Jirovecii Pneumonia. The quantity of dosage varies, as per the administration strategy (e.g. Tablet - Oral or Tablet) detailed in the accompanying table.

Condition

Dosage

Administration

Conjunctivitis, Bacterial

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

Pneumonia, Pneumocystis

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

Brucellosis

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

Immunocompromised

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

Nocardiosis

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

Urinary tract infection

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

bacterial blepharitis caused by susceptible bacteria

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

Urinary tract infection

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

Diarrhea

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

Shigellosis

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

Electrolyte replacement

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

Fluid replacement therapy

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

Genus Pneumocystis

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

Bacterial conjunctivitis

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

Bronchitis

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

susceptible Enteritis infectious caused by Shigella flexneri

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

susceptible Enteritis infectious caused by Shigella sonnei

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

Otitis Media

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

Cholera

, 1.0 mg/mL, 160.0 mg, 80.0 mg, 40.0 mg/mL, 50.0 mg/mL, 100.0 mg, 0.16 mg, 1.6 mg, 20.0 mg, 200.0 mg, 90.0 mg, 16.0 mg/mL, 300.0 mg, 40.0 mg, 8.0 mg/mL, 9.0 mg/mL

Solution / drops - Ophthalmic, , Ophthalmic, Tablet - Oral, Oral, Tablet, Solution, Solution - Oral, Solution - Ophthalmic, Suspension - Oral, Suspension, Injection, solution, concentrate - Intravenous, Solution - Intravenous, Intravenous, Solution / drops, Liquid - Ophthalmic, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection - Intravenous, Injection

Warnings

Primsol has eight contraindications, so it should be avoided in cases of the afflictions listed in the ensuing table.

Primsol Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Trimethoprim may interact with Pulse Frequency

Purpura, Thrombocytopenic, Idiopathic

Do Not Combine

hepatic damage

Do Not Combine

Megaloblastic anemia caused by Folate deficiency

Do Not Combine

unable to monitor renal function

Do Not Combine

Disease

Do Not Combine

Pulse Frequency

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Trimethoprim may interact with Pulse Frequency

There are 20 known major drug interactions with Primsol.

Common Primsol Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The excretion of Abemaciclib can be decreased when combined with Trimethoprim.

Brigatinib

Major

The metabolism of Brigatinib can be decreased when combined with Trimethoprim.

Cabazitaxel

Major

The metabolism of Cabazitaxel can be decreased when combined with Trimethoprim.

Cisplatin

Major

The serum concentration of Cisplatin can be increased when it is combined with Trimethoprim.

Clofarabine

Major

The serum concentration of Clofarabine can be increased when it is combined with Trimethoprim.

Primsol Toxicity & Overdose Risk

The most toxic dose of trimethoprim in mice and rats is 2764 mg/kg and over 5300 mg/kg, respectively. Taking more than 1 gram of trimethoprim can cause symptoms such as nausea, vomiting, dizziness, headaches, depression, confusion, and a decrease in red blood cells. Treatment should include supportive care and rinsing the stomach if necessary. Acidic urine can help to remove trimethoprim from the body more quickly, but dialysis is only moderately effective.

image of a doctor in a lab doing drug, clinical research

Primsol Novel Uses: Which Conditions Have a Clinical Trial Featuring Primsol?

Eight active studies are currently investigating the potential of Primsol in treating Shigella flexneri-induced Enteritis, Bacterial-induced Blepharoconjunctivitis, and Diarrhea.

Condition

Clinical Trials

Trial Phases

Urinary tract infection

0 Actively Recruiting

Bacterial conjunctivitis

0 Actively Recruiting

Bronchitis

0 Actively Recruiting

Nocardiosis

0 Actively Recruiting

Shigellosis

0 Actively Recruiting

Brucellosis

0 Actively Recruiting

bacterial blepharitis caused by susceptible bacteria

0 Actively Recruiting

Immunocompromised

2 Actively Recruiting

Phase 1, Not Applicable

Otitis Media

0 Actively Recruiting

Genus Pneumocystis

0 Actively Recruiting

Conjunctivitis, Bacterial

0 Actively Recruiting

Fluid replacement therapy

0 Actively Recruiting

Cholera

0 Actively Recruiting

Urinary tract infection

0 Actively Recruiting

susceptible Enteritis infectious caused by Shigella sonnei

0 Actively Recruiting

Pneumonia, Pneumocystis

2 Actively Recruiting

Phase 3, Phase 4

susceptible Enteritis infectious caused by Shigella flexneri

0 Actively Recruiting

Electrolyte replacement

0 Actively Recruiting

Diarrhea

12 Actively Recruiting

Not Applicable, Phase 2, Early Phase 1, Phase 1

Patient Q&A Section about primsol

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is trimethoprim used to treat?

"Trimethoprim is an antibiotic medication prescribed to treat and prevent urinary tract infections, as well as other infections such as chest infections and acne."

Answered by AI

What is Ciprodenk used for?

"This medication is a broad-spectrum antibiotic used to treat bacterial infections of the urinary tract, nose, throat, skin, and soft tissues. It is also effective against pneumonia."

Answered by AI

What are the side effects of taking trimethoprim?

"You may have internal bleeding if you experience any of the following: dark, sticky stool, blood in your urine or stool, fingers or lips that look blue, changes to the color of your facial skin, difficulty breathing or feeling short of breath, a fever with or without chills, feeling generally unwell or sick, or stiffness in your neck."

Answered by AI

What is Primsol used for?

"Primsol is an antibiotic used to treat bladder or kidney infections, or ear infections caused by certain bacteria."

Answered by AI

Clinical Trials for Primsol

Image of McGill university Health Centre (Royal victoria Hospital and Montreal General Hospital in Montreal, Canada.

Systemic Corticosteroids for Pneumocystis Pneumonia

18+
All Sexes
Montreal, Canada

The HOW LONG trial is an international, multicenter, Phase IV randomized clinical trial evaluating the optimal duration of adjunctive systemic corticosteroids in immunocompromised adults with severe Pneumocystis jirovecii pneumonia (PCP) who demonstrate early clinical recovery. Participants who no longer require supplemental oxygen by day 10 of corticosteroid therapy are randomized to discontinue corticosteroids at day 10 (or hospital discharge, if earlier) versus continue corticosteroids for a total of 21 days. The trial assesses whether earlier discontinuation reduces steroid-related complications while maintaining clinical outcomes.

Phase 4
Waitlist Available

McGill university Health Centre (Royal victoria Hospital and Montreal General Hospital

Image of Stanford Digestive Health Clinic in Redwood City, United States.

MITI-001 for Irritable Bowel Syndrome

18 - 65
All Sexes
Redwood City, CA

While the pathophysiology of diarrhea-predominant irritable bowel syndrome (IBS-D) is complex and heterogeneous, dysbiosis of the gut microbiome is frequently observed, suggesting that a substantial subset of patients with irritable bowel syndrome (IBS) have symptoms that are initiated and/or perpetuated by a microbiome dysfunction. Successful randomized controlled trials (RCT) for IBS-D (Ford 2018; Black 2022) leveraging microbiome-targeted therapies (antibiotics or low microbiome fermentation diets) suggest the gut microbiome is at least partially involved in IBS symptoms. Furthermore, fecal microbiota transplantation (FMT) for patients with IBS-D has demonstrated promising results (El-Salhy 2020), supporting the possibility that altering the microbiome composition could ameliorate IBS-D symptoms. MITI-001 is a transplantable gut bacterial community composed of 157 live bacterial strains, encompassing 79 genera of commensal bacteria, that have been isolated from healthy donor stool, purified, and banked. The hypothesis of the proposed research is that MITI-001 can target the pathophysiologic lesion in a subset of IBS-D patients, restore the altered microbial metabolic process, and thus alleviate IBS-D symptoms.

Phase < 1
Waitlist Available

Stanford Digestive Health Clinic (+1 Sites)

Sean P Spencer, MD, PhD

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Image of University of Maryland, School of Medicine, Center for Vaccine Development and Global Health in Baltimore, United States.

Vaccine for E. coli Infections

18 - 49
All Sexes
Baltimore, MD

The study is designed to evaluate the safety, immunogenicity, and efficacy of the intramuscular administration of a CS6 based vaccine (CssBA) against ETEC co-administered with double mutant labile toxin (dmLT) in preventing moderate-severe diarrhea (MSD) following challenge with ETEC strain B7A in healthy adults. Approximately 72 adult participants, divided into 4 cohorts of 18, will be randomized 1:1 to receive vaccine (45 micrograms CssBA with 0.5 micrograms dmLT) or placebo (normal saline) on an outpatient basis. All participants will receive 3 intramuscular (IM) doses of vaccine or placebo at 3-week intervals (days 1, 22 and 43). Following vaccination, participants will be followed as outpatients for safety using a memory aid from the time of each vaccination through 7 days post each vaccination. Approximately 28 days (plus or minus 1 day) after receipt of the 3rd dose of study agent, participants meeting challenge criteria will be admitted to an inpatient unit and be administered an oral dose of 1 x 10\^10 cfu (colony-forming unit) of ETEC strain B7A. Five days after challenge, participants will be treated with ciprofloxacin, except in cases of known allergy or intolerance. Participants will be discharged from the inpatient unit when they have completed their 3-day antibiotic course and are able to care for themselves. After discharge from the inpatient unit, participants will return for clinic visits and have a phone visit to provide any updates on medication, medical history and AE/SAEs. The primary objectives are: 1) Estimate CssBA+dmLT efficacy in preventing moderate-severe diarrhea (MSD) following challenge with ETEC strain B7A in healthy adults. 2) Evaluate the safety of intramuscular injection of CssBA+dmLT.

Phase 2
Waitlist Available

University of Maryland, School of Medicine, Center for Vaccine Development and Global Health (+1 Sites)

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We made a collection of clinical trials featuring Primsol, we think they might fit your search criteria.
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Image of McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital) in Montreal, Canada.

Low-Dose Trimethoprim-Sulfamethoxazole for Pneumocystis Pneumonia

18 - 100
All Sexes
Montreal, Canada

Pneumocystis jirovecii pneumonia (PJP) is an opportunistic fungal infection of immunocompromised hosts which causes in significant morbidity and mortality. The current standard of care, trimethoprim-sulfamethoxazole (TMP-SMX) at a dose of 15-20 mg/kg/day of TMP, is associated with serious adverse events, including hypersensitivity reactions, drug-induced liver injury, cytopenia, and renal failure occurring among 20-60% of patients. The frequency of adverse events increases in a dose dependent manner and commonly limits the use of TMP-SMX. Reduced treatment doses of TMP-SMX for PJP reduced ADEs without mortality differences in a recent meta-analysis of observational studies. We therefore propose a Phase III randomized, placebo-controlled trial to directly compare the efficacy and safety of low dose (10 mg/kg/day of TMP) compared to the standard-of-care (15 mg/kg/day) among patients with PJP for the primary outcome of death, new mechanical ventilation, and change of treatment.

Phase 3
Waitlist Available

McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)

Emily G McDonald, MD MSc

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We made a collection of clinical trials featuring Primsol, we think they might fit your search criteria.
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