CompletedPhase 2

Combined Inhalational With Intravenous Amphotericin B Versus Intravenous Amphotericin B Alone for Pulmonary Mucormycosis

India30 participantsStarted 2020-07-01

Plain-language summary

To assess the safety and feasibility of combined inhalational and intravenous amphotericin B therapy for the treatment of pulmonary mucormycosis. And compare the efficacy of combined therapy with that of intravenous amphotericin B alone.

Who can participate

Age range12 Years

SexALL

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Inclusion Criteria: Subjects with a clinicoradiologic suspicion of pulmonary mucormycosis will be enrolled if the diagnosis of mucormycosis is pathologically or microbiologically (smear showing aseptate hyphae, culture or molecular evidence showing Mucorales) confirmed. Cases of disseminated mucormycosis will be included, only if the pulmonary infection is confirmed pathologically or microbiologically from respiratory secretions or biopsy samples Exclusion Criteria: * Lack of informed consent * Hypersensitivity to amphotericin B or any component of the formulation * Pregnancy * High likelihood of death within 48 h of enrolment * Suspected pulmonary mucormycosis without histological or microbiologic proof

What they're measuring

Overall response (clinical and radiological improvement) at the end of six weeks of start of therapy

Timeframe: 6 weeks after the start of therapy

Adverse events related to therapy

Timeframe: till 6 weeks from randomization (start of therapy)

Trial details

NCT IDNCT04502381

SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-30

View on ClinicalTrials.gov More Pulmonary Mucormycosis trials