Health TrialsbyHealthPanel

Rezafungin for Treatment of Pneumocystis Pneumonia in HIV Adults

ConditionPneumocystis Pneumonia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMundipharma Research Limited

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 reaction [PCR]). Participants who are newly diagnosed with HIV infection by an antigen/antibody combination HIV-1/2 immunoassay are allowed to be included in the study, but the infection should be subsequently confirmed by an HIV-1/HIV-2 antibody differentiation immunoassay or nucleic acid tests.

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 consent on the participant's behalf.

Disqualifiers

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 (e.g., Stevens-Johnson syndrome or toxic epidermal necrolysis).

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, but not limited to, acute porphyria or a history of drug-induced immune thrombocytopaenia with use of trimethoprim and/or sulphonamides.

Creatinine clearance <15 mL/min or receiving renal replacement therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Co-Trimoxazole

    Drug

    Oral co-trimoxazole or Intravenous (IV) co-trimoxazole for infusion. Anti fungal medication

  • Rezafungin Acetate / Co Trimoxazole

    Drug

    Rezafungin for infusion. Intravenous anti fungal therapy Oral co-trimoxazole or Intravenous (IV) co-trimoxazole for infusion. Anti fungal medication

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Rezafungin Acetate /Co-trimoxazoleExperimental treatment 1 intervention
Group B: Co-trimoxazoleActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Therapeutic failure on Day 8

Therapeutic failure on Day 8, defined by one of the following and confirmed by an independent, blinded Data Review Committee (DRC): * Clinical deterioration. The deterioration cannot be solely explained by other infections or causes and is defined as an increase in score of 2 points or more from the score prior to randomisation on Day 1 on the Ordinal Scale for Clinical Improvement (OSCI), as assessed by the Investigator. * Requirement for alternative primary therapy for PCP, or intensification of corticosteroid therapy, due to lack of efficacy (as assessed by the Investigator). * Death from any cause.

Time frame
8 days

Secondary outcomes

1

Therapeutic failure at any time during the treatment period (from Day 1 to Day 21)

Therapeutic failure at any time during the treatment period (from Day 1 to Day 21) defined by one of the following and confirmed by an independent, blinded Data Review Committee (DRC): * Clinical deterioration. The deterioration cannot be solely explained by other infections or causes and is defined as an increase in score of 2 points or more from the score prior to randomisation on Day 1 on the Ordinal Scale for Clinical Improvement (OSCI), as assessed by the Investigator. * Requirement for alternative primary therapy for PCP, or intensification of corticosteroid therapy, due to lack of efficacy (as assessed by the Investigator). * Death from any cause.

Time frame
21 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mundipharma Research Limited

Lead sponsor

Source ClinicalTrials.gov
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