Status:
COMPLETED
Combined Inhalational With Intravenous Amphotericin B Versus Intravenous Amphotericin B Alone for Pulmonary Mucormycosis
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Pulmonary Mucormycosis
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Pulmonary mucormycosis is a relatively a rare disease with a high mortality. The angioinvasion associated with mucormycosis prevents efficient drug delivery at the diseased site. Inhaled amphotericin ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04502381
Start Date
July 1 2020
End Date
December 30 2021
Last Update
November 27 2023
Active Locations (1)
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1
Post graduate Institute medical education and research
Chandigarh, India, 160012