Trimpex

Shigellosis, Nocardiosis, Brucellosis + 16 more

Treatment

17 FDA approvals

16 Active Studies for Trimpex

What is Trimpex

Trimethoprim

The Generic name of this drug

Treatment Summary

Trimethoprim is an antibiotic medicine used to treat bacterial infections. It works by blocking the formation of an important enzyme that helps the bacteria survive. It is usually taken with another antibiotic, sulfamethoxazole, for maximum effectiveness. It is related to pyrimethamine, another antibiotic used to treat malaria.

Septra DS

is the brand name

Trimpex 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 Trimpex Affects Patients

Trimethoprim works by stopping bacteria from making the proteins and nucleic acids they need to survive. It is effective against some types of gram-negative bacteria and certain types of Staphylococcus. Bacteria can become resistant to trimethoprim if they make changes to their cell wall, produce more of an enzyme (dihydrofolate reductase) or make an enzyme that is resistant to trimethoprim. Taking trimethoprim can sometimes lead to blood disorders such as thrombocytopenia and leukopenia. It is important to watch for signs of these disorders such

How Trimpex works in the body

Trimethoprim is a medication that works to kill bacteria. It does this by stopping bacteria from making a type of acid, called tetrahydrofolic acid, which they need to survive. Trimethoprim works better on bacteria than on human cells, so it only affects bacteria, not people. Trimethoprim can be taken alone or with another medication, sulfamethoxazole, which works in a similar way. Together, these two medications block two steps in the process of bacterial growth, making them more effective at killing bacteria.

When to interrupt dosage

The suggested dose of Trimpex is contingent upon the diagnosed condition, including Urinary tract infection, Immunocompromised and Pneumocystis Jirovecii Pneumonia. The amount additionally depends on the method of delivery (e.g. Tablet - Oral or Tablet) outlined in the table below.

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

Warnings

Trimpex has eight contraindications and should not be administered concurrently with any of the disorders listed in the following table.

Trimpex 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 Trimpex.

Common Trimpex 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.

Trimpex Toxicity & Overdose Risk

The toxic dose of trimethoprim for mice and rats is 2764 mg/kg and greater than 5300 mg/kg respectively. Signs of overdose may appear if the patient has taken more than 1 gram of trimethoprim, including nausea, vomiting, dizziness, headaches, confusion, and reduced bone marrow function. Treatment should include supportive care and potentially stomach pumping, as well as increasing acidity in the urine to help remove the drug from the body. Dialysis is only partially effective in removing trimethoprim from the bloodstream.

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

Currently, 8 clinical trials are being conducted to assess the effectiveness of Trimpex in treating Shigella flexneri-induced Enteritis Infectious, 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 trimpex

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

What is trimethoprim prescribed for?

"Trimethoprim is a medication used to treat and prevent urinary tract infections. It can also be used to treat other types of infections such as chest infections and acne, though this is less common. Trimethoprim requires a prescription from a doctor."

Answered by AI

What are the side effects of taking trimethoprim?

"The following are symptoms of oxygen deprivation: black, tarry stools; blood in urine or stools; bluish fingernails, lips, or skin; changes in facial skin color; difficult breathing or shortness of breath; fever with or without chills; general feeling of discomfort or illness; neck stiffness."

Answered by AI

What is Proloprim used for?

"It is used to treat bacterial infections."

Answered by AI

What is Trimpex used for?

"Trimethoprim is used to treat bacterial infections. It stops the growth of the bacteria. This antibiotic only works for bacterial infections and won't work for viral infections like the common cold or the flu."

Answered by AI

Clinical Trials for Trimpex

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 Trimpex, 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 Trimpex, we think they might fit your search criteria.
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