Clinical trial NCT04502381: Combined Inhalational With Intravenous Amphotericin B Versus Intravenous Amphotericin B Alone for Pulmonary Mucormycosis
Official title: A Randomized Controlled Trial of Combined Inhalational With Intravenous Amphotericin B in Comparison With Intravenous Amphotericin B Alone for Treatment of Pulmonary Mucormycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Mucormycosis
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2020-08-06
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 of intravenous amphotericin B alone.

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 B achieves drug levels in lung tissue and has been shown to be useful in several diseases including chronic pulmonary and allergic bronchopulmonary aspergillosis. Further inhaled forms of amphotericin B are associated with less nephrotoxicity and other systemic adverse effects. The role of inhaled amphotericin B in pulmonary mucormycosis has been previously demonstrated in murine models and anecdotal reports. The study hypothesis is that combined therapy with inhalational and intravenous amphotericin B is likely to result in better outcomes as compared with intravenous amphotericin B alone for treatment of pulmonary mucormycosis

Eligibility criteria: 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

Primary outcomes:
measure: Overall response (clinical and radiological improvement) at the end of six weeks of start of therapy
timeFrame: 6 weeks after the start of therapy
measure: Adverse events related to therapy
timeFrame: till 6 weeks from randomization (start of therapy)
Secondary outcomes:
measure: In-hospital mortality
timeFrame: During hospital stay, approximately till 6 weeks from randomization (start of therapy)
measure: 90 day mortality
timeFrame: 90 days from the date of randomization
measure: Proportion of subjects requiring discontinuation or modification of therapy due to adverse events
timeFrame: till 6 weeks from randomization (start of therapy)
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post graduate Institute medical education and research
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Ratnakara Rao, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: