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Topical Antifungal Therapy in COVID Associated Mucormycosis: A new hope?

A Multi-arm, parallel Randomised Control Trial to compare the efficacy of 0.1% w/w Liposomal Amphotericin-B gel with 10% w/w povidine-iodine and saline nasal douching in preventing revision surgery in patients with COVID associated mucormycosis and to develop AIIMS Bhubaneswar Mucormycosis Endoscopic Scoring System (AMESS) for quantification of response to treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037257
Enrollment
45
Registered
2021-10-12
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: 0.1% w/w Lipid based Liposomal Amphotericin-B gel 1mg/gm application in postoperative cavity of patients undergoing open or endoscopic debridement for COVID Associated Mucormycosis: Ser

Sponsors

Dr Zaid Shaikh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients were microbiologically and histologically proven cases of mucormycosis and underwent open or endoscopic surgical debridement for Mucormycosis. Patients must have received a minimum of three weeks of systemic Amphotericin B administration postoperatively without any discontinuity

Exclusion criteria

Exclusion criteria: Patients having mandibular or disseminated forms of mucormycosis, where study participants refused giving prior consent of participation. Patients who were deceased before three weeks or had interruption in treatment with systemic Amphotericin B

Design outcomes

Primary

MeasureTime frame
Primary outcome is to assess the number of patients requiring revision surgery for mucormycosis residual/recurrenceTimepoint: Postoperative day 7, 14 and 21 evaluation—

Secondary

MeasureTime frame
AIIMS Bhubaneswar Mucormycosis Endoscopic Scoring System (AMESS) and its association with Revision surgeryTimepoint: Within 21 days of primary surgery—

Countries

India

Contacts

Public ContactDr Chappity Preetam

AIIMS Bhubaneswar

drcpreetam@aiimsbhubaneswar.edu.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 12, 2026