Clinical trial
A Randomized Controlled Trial of Combined Inhalational With Intravenous Amphotericin B in Comparison With Intravenous Amphotericin B Alone for Treatment of Pulmonary Mucormycosis
Name
NK/6146/DM/452
Description
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.
Trial arms
Trial start
2020-07-01
Estimated PCD
2021-10-30
Trial end
2021-12-30
Status
Completed
Phase
Early phase I
Treatment
Inhaled amp B deoxycholate+intravenous liposomal amp B
Intravenous liposomal amphotericin B (beginning with 3mg/kg) along with inhaled amphotericin as below: Amp-B deoxycholate 50 mg (Amphotret™ Bharat serums and vaccines limited), will be dissolved in 10 mL distilled water. 2 mL of the reconstituted amphotericin B solution will be transferred into the drug chamber of a breath actuated nebulizer (Lupineb Ultra kit breath actuated nebulize which contains aeroclipse XL Reusable Breath Actuated Nebulizer and DeVilbiss 3655 compressor). 3 mL of distilled water is added to 2 mL of the reconstituted amphotericin B. The nebulization is continued till the chamber is emptied of the drug or the patient does not tolerate the therapy.
The first three doses of amphotericin B nebulization will be under the direct supervision of a physician. If tolerated, nebulization will be continued twice a day till tolerated or till response.The patient will complete a VAS score for cough after nebulization.
Arms:
Intervention arm
Intravenous liposomal amphotericin B alone
Intravenous liposomal amphotericin B (beginning with 3mg/kg, up to 5 mg/kg), with or without surgery or other antifungals as clinically indicated
Arms:
Conventional arm, Intervention arm
Size
30
Primary endpoint
Overall response (clinical and radiological improvement) at the end of six weeks of start of therapy
6 weeks after the start of therapy
Adverse events related to therapy
till 6 weeks from randomization (start of therapy)
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2023-11-27
1 organization
2 products
1 indication
Indication
Mucormycosis