trimethoprim-sulfamethoxazole for Pneumocystis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital), Montreal, Canada
Pneumocystis+11 More
trimethoprim-sulfamethoxazole - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a lower dose of TMP-SMX is as effective as the standard dose of TMP-SMX in treating PJP.

See full description

Eligible Conditions

  • Pneumocystis
  • Pneumocystis Carinii; Infection, Resulting From HIV Disease
  • Pneumocystis Jirovecii Infection
  • Pneumocystosis Associated With AIDS
  • Pneumocystis Infections
  • Pneumocystis Carinii Infection
  • Pneumocystis Jirovecii Pneumonia
  • Pneumocystosis; Pneumonia (Etiology)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether trimethoprim-sulfamethoxazole will improve 1 primary outcome, 14 secondary outcomes, and 2 other outcomes in patients with Pneumocystis. Measurement will happen over the course of 21 days.

21 days
Proportion requiring new non-invasive ventilation
Proportion who die
Proportion who require new mechanical ventilation
Proportion with Skin rash
Proportion with Treatment failure
Proportion with drug-induced hepatitis
Proportion with hyperkalemia
Proportion with hypoglycemia
Proportion with new cytopenias
Proportion with new renal failure
Proportion with treatment change due to inefficacy
Proportion with treatment change due to toxicity
90 days
Proportion with all cause mortality
Proportion with at least 1 recurrence of Pneumocystis
Day 21
Proportion with ongoing oxygen need
Day 28
EQ-5D-5L
Quality of life measured by visual analog scale

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Standard dose TMP-SMX
1 of 2
Reduced dose TMP-SMX
1 of 2
Active Control
Experimental Treatment

This trial requires 300 total participants across 2 different treatment groups

This trial involves 2 different treatments. Trimethoprim-sulfamethoxazole is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Reduced dose TMP-SMX
Drug
Trimethoprim-Sulfamethoxazole at a total dose of 10mg/kg/day. Oral or intravenous drug will be administered at discretion of treating team. This will be given as a dose of 10mg/kg/day open label with additional placebo tablets or intravenous placebo solution given to simulate 15mg/kg/day. All doses will be adjusted for obesity and renal function.
Standard dose TMP-SMX
Drug
Trimethoprim-Sulfamethoxazole at a total dose of 15mg/kg/day. Oral or intravenous drug will be administered at discretion of treating team. This will be given as 10mg/kg/day open label plus an extra masked 5mg/kg/day of tablets or intravenous solution. All doses will be adjusted for obesity and renal function.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trimethoprim
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 90 days for reporting.

Who is running the study

Principal Investigator
T. C. L. F.
Prof. Todd C. Lee FIDSA, MD
McGill University Health Centre/Research Institute of the McGill University Health Centre

Closest Location

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

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Immunocompromised (including but not limited to HIV, solid organ transplant, solid tumors, hematological stem cell transplant and malignancies, systemic diseases, chemotherapy, long term corticosteroid use, and immunosuppressive therapies, as well as primary immunodeficiencies
Presentation to a day hospital, emergency department, or admitted to hospital
Proven or probable diagnosis of PJP using an adapted version of the 2021 EORTC/MSGERC criteria.

Patient Q&A Section

What are the signs of pneumocystis infections?

"The signs of PCP include fever (72%), weight loss (35%), malaise (22%), and jaundice (5%). Hematological abnormalities and disseminated intravascular coagulation are uncommon. Although pneumocystiasis has no typical histology, the finding of epithelial cells, fibrous stroma, or necrotic nodules suggests infectious pneumonia. The finding of pneumocysts in the liver indicates that PCP has disseminated the infection to the liver, which has not been described previously. Atypical PCP may be misdiagnosed as tuberculosis, cryptococcus, or histoplasmosis." - Anonymous Online Contributor

Unverified Answer

What are common treatments for pneumocystis infections?

"The incidence of Pneumocystis pneumonia has been decreasing. Most cases are treated with inhaled and/or intravenous therapy. Pneumocystis Pneumonia is a rare but life-threatening disease. Its prognosis depends upon severity and whether the patient is immunocompromised. The mortality ratio for Pneumocystis pneumonia is approximately 0.3%. Patients who are mechanically ventilated and are receiving high doses of corticosteroids have a greater mortality rate than patients who are not receiving these high doses. Antibiotics, regardless of the route, are highly effective in cases of Pneumocystis Pneumonia." - Anonymous Online Contributor

Unverified Answer

What causes pneumocystis infections?

"In this series, P. aeruginosa was found only in 10% of patients with P. jirovecii infection as a primary diagnosis. The association of P. jirovecii and P. aeruginosa infections was independent of other factors. The possible role of other pathogens remains to be defined." - Anonymous Online Contributor

Unverified Answer

How many people get pneumocystis infections a year in the United States?

"Approximately 50 % of people without pre-existing lung disease have signs/symptoms of P. carinii pneumonia (PCP) at some time in their lives. About 80 % of people that do not have this history are diagnosed with PCP as long as they have a positive P. carinii pneumonia IgG serology at some point in their lives. Approximately 60% of people that are diagnosed with PCP do not exhibit symptoms. About 20% of people who are diagnosed with PCP will develop symptomatic disease within three months. PCP can recur in the same person repeatedly over many years. How often PCP occurs in a specific population remains to be determined. P." - Anonymous Online Contributor

Unverified Answer

Can pneumocystis infections be cured?

"Pneumocystis jiroveci pneumonia after SOT can be managed medically and without any specific antiviral prophylaxis if Pneumocystis jiroveci infection is definitively ruled out, and no identifiable fungal or bacterial pathogens are cultured from samples submitted for further testing." - Anonymous Online Contributor

Unverified Answer

What is pneumocystis infections?

"Pneumocystis pneumonia is a life-threatening opportunistic infection which most commonly starts when patients are immunocompromised, such as infected by HIV and undergoing chemotherapy. Pneumocystis infections can be life-threatening in the immunocompromised host, and can be lethal in immunocompetent hosts with the compromised immune defenses. \n" - Anonymous Online Contributor

Unverified Answer

What is the latest research for pneumocystis infections?

"A recent update to the data for pneumocystis infections demonstrates a general increase in the global incidence of PCP. The underlying causes, patient-related risk factors, and prognosis for patients with PCP has not changed substantially over time. These factors appear to have been largely unchanged over recent years. Further research into the pathogenesis and treatment of PCP is crucial to assure a continued decrease in this disease and its consequences." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets pneumocystis infections?

"Results from a recent paper provides estimates of the average age of people who get PCP infections and estimates the number of cases, both over time and in different countries. Results from a recent paper also allows an examination of how a change in the age of people at risk may affect the number of cases." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving trimethoprim-sulfamethoxazole?

"There were no clinical trials that took place before the trial using trimethoprim-sulfamethoxazole to treat pneumocystis pneumonia. However, there were six studies that showed a benefit in patients who already had pneumocystis pneumonia. However, there were no studies that looked at trimethoprim-sulfamethoxazole in patients with previous pneumocystis infections." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of pneumocystis infections?

"The primary causes of P. pneumoniae pneumonias relate to patient factors, particularly immunosuppressive state and age. These data may guide the use of specific antibiotics and specific management of patients with P. pneumoniae pneumonias." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in trimethoprim-sulfamethoxazole for therapeutic use?

"Sulfamethoxazole-trimethoprim was discontinued in the United States because of the development of trimethoprim-sulfamethoxazole resistance. Resistance to sulfamethoxazole-trimethoprim exists in emerging countries, and trimethoprim-sulfamethoxazole is now routinely prescribed in the treatment of tuberculosis. New formulations are under study, such as trimethoprim-nitroso-sulfamethoxazole (TMP/NOX, Dantrolisin, Septron) as salvage therapy for resistant organisms or for prevention of P. aeruginosa infections in immunocompromised or otherwise severely critically ill patients." - Anonymous Online Contributor

Unverified Answer

Is trimethoprim-sulfamethoxazole typically used in combination with any other treatments?

"This analysis demonstrates that trimethoprim-sulfamethoxazole is commonly used in combination with other antimicrobial treatments. Further investigation and more rigorous data collection are recommended to increase the validity of this analysis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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