BridgeMD
New treatment option for Pneumocystis Pneumonia
Official title Rezafungin for Treatment of Pneumocystis Pneumonia in HIV Adults
ClinicalTrials.gov ID: NCT05835479
What this study is testing
What is Co-Trimoxazole?
Co-Trimoxazole is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pneumocystis pneumonia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to generate clinical data on the efficacy, safety, and tolerability of rezafungin combined with 7 days of co-trimoxazole for treatment of Pneumocystis pneumonia (PCP) in adults living with human immunodeficiency virus (HIV), which would expand the knowledge of clinical use of rezafungin.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Males or females at least 18 years of age.
- Tested positive for HIV by either blood antigen/antibody combination HIV-1/2 immunoassay, HIV-1/HIV-2 antibody differentiation immunoassay, or...
- Diagnosed with definitive, presumptive, or clinically suspected PCP prior to randomisation.
- Willing and able to provide written informed consent. If the participant is unable to provide consent, a legally acceptable representative (i.e...
- Participants of childbearing potential (all biologically female participants between 18 years and \<2 years post-menopausal unless surgically...
You likely can't join if
- Under 18 years of age.
- Known or suspected hypersensitivity or allergic reaction to co-trimoxazole, rezafungin, any echinocandin, or any component of these formulations...
- Any contraindication to co-trimoxazole or intake of a medication or supplement known to severely interact with co-trimoxazole as detailed in the...
- Creatinine clearance \<15 mL/min or receiving renal replacement therapy.
- Severe hepatic impairment, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5 × upper limits of normal (ULN), or total...
- A neutrophil count \<1,000 cells/µL or a platelet count \<50,000 cells/µL.
See the full eligibility criteria
Who can join
- Males or females at least 18 years of age.
- Tested positive for HIV by either blood antigen/antibody combination HIV-1/2 immunoassay, HIV-1/HIV-2 antibody differentiation immunoassay, or nucleic acid tests (e.g., HIV ribonucleic acid [RNA] polymerase chain...
- Diagnosed with definitive, presumptive, or clinically suspected PCP prior to randomisation.
- Willing and able to provide written informed consent. If the participant is unable to provide consent, a legally acceptable representative (i.e., acceptable to ICH and local law, as applicable) must provide informed...
- Participants of childbearing potential (all biologically female participants between 18 years and \<2 years post-menopausal unless surgically sterile) must agree to use a highly effective contraceptive measure during...
- Biologically male participants who are not vasectomised must agree to the following requirements during the study period (from enrolment) and for at least 120 days after the last dose of rezafungin:
- Refrain from donating sperm PLUS, either
- Abstain from sexual intercourse with a female of childbearing potential as their preferred and usual lifestyle OR
- Use barrier contraception (i.e., male condom with or without spermicide) when having sexual intercourse with a female of childbearing potential who is not currently pregnant.
What rules you out
- Under 18 years of age.
- Known or suspected hypersensitivity or allergic reaction to co-trimoxazole, rezafungin, any echinocandin, or any component of these formulations, including, but not limited to, anaphylaxis or exfoliative skin disorders...
- Any contraindication to co-trimoxazole or intake of a medication or supplement known to severely interact with co-trimoxazole as detailed in the Summary of Product Characteristics (SmPC) of co-trimoxazole, including...
- Creatinine clearance \<15 mL/min or receiving renal replacement therapy.
- Severe hepatic impairment, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5 × upper limits of normal (ULN), or total bilirubin \>3 × ULN, or a history of chronic cirrhosis (Child-Pugh...
- A neutrophil count \<1,000 cells/µL or a platelet count \<50,000 cells/µL.
- Immunosuppressive disease other than HIV / acquired immunodeficiency syndrome (AIDS) (e.g., haematopoietic stem cell transplant, solid organ transplant, or primary immune deficiencies) OR prolonged use of...
- Having received corticosteroids equivalent to prednisone ≥20 mg daily for at least 14 consecutive days within 30 days prior to study entry, or
- Having received biologics (e.g., infliximab, ustekinumab), immunomodulators (e.g., methotrexate, mercaptopurine, azathioprine), or cancer chemotherapy within 90 days prior to study entry.
- Previously diagnosed with PCP and having received treatment in the past 6 weeks.
- Receiving therapy for PCP at approved therapeutic doses for \>48 hours before randomisation. Exception: receipt of an anti-PCP drug at prophylactic doses (i.e., lower than approved therapeutic doses).
- Meeting National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 criteria for ataxia, tremors, motor neuropathy, or sensory neuropathy of Grade 2 or higher.
- History of severe ataxia, tremors, or neuropathy or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's disease and Huntington's disease).
- Planned or ongoing therapy at Screening with a known severe neurotoxic medication or with a known moderate neurotoxic medication in a participant with ataxia, tremors, motor neuropathy, or sensory neuropathy of...
- Previous participation in this or any other rezafungin study.
- Female participants who are pregnant or lactating.
- Having a concomitant disease or any medical condition (including other HIV-associated infection or complication) that, in the opinion of the Investigator, could pose undue risk to the participant, impede completion of...
- Receipt of an investigational drug within 30 days prior to dosing of the study drug(s), presence of an investigational device at the time of Screening, or is planning to participate in another treatment clinical study...
- The Investigator is of the opinion the participant should not participate in the study. Late Exclusion Criteria: The diagnosis of PCP will be reviewed by the Investigator on Day 8 (before dosing the study drug)...
- Lack of positive P. jirovecii immunofluorescence or PCR of bronchoalveolar lavage, endotracheal aspirates, bronchoscopic tissue biopsy, or induced sputum AND serum β-D-glucan below the positive cut-off value.
- Serum β-D-glucan below the positive cut-off value in participants in whom collection of a suitable respiratory sample is not possible.
- Radiographic features on chest CT performed after randomisation not consistent with PCP after taking into account the clinical and microbiological findings.
The study team makes the final eligibility decision.
Where it's taking place
- Cape Town, South Africa
- Johannesburg, South Africa
- Pretoria, South Africa
- Umhlanga, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cape Town, South Africa; Johannesburg, South Africa; Pretoria, South Africa; Umhlanga, South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.