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Study of application of amphotericin into the nose for prevention of fungal infection in COVID positive patients

Topical amphotericin via intranasal route in covid positive patients at risk for invasive fungal sinusitis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/034543
Enrollment
246
Registered
2021-07-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: standard care and amphotericin B: Standard of care+ Intervention- Intranasal amphotericin B preparation, Patient advised to instil dilute amphotericin nasal drops into both nostrils 3 t

Sponsors

Department of ENT
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - pre-existing diabetes mellitus at the time of admission - in those without diagnosed diabetes at baseline, a fasting or random blood glucose level > 200 mg/ dl at any time point during admission - patients who have received >=6 mg/day of Dexamethasone or >=30mg/day of methylprednisolone - patients receiving immunomodulators for at least 24 hours - patients receiving systemic anti-bacterial drugs - patients with hematologic malignancies - receiving bone marrow transplant/ systemic chemotherapy/ HIV-AIDS/ immunosuppressive therapy after organ transplant

Exclusion criteria

Exclusion criteria: 1. COVID 19 patients with evidence of mucor mycosis at screening or randomization 2. COVID 19patients with features of invasive fungal sinusitis at screening or randomization

Design outcomes

Primary

MeasureTime frame
Proportion of COVID positive patients at risk for invasive fungal sinusitis developing mucor mycosisTimepoint: 14 days

Secondary

MeasureTime frame
Proportion of COVID positive patients at risk for invasive fungal sinusitis developing mucor mycosisTimepoint: 28 days

Countries

India

Contacts

Public ContactDr Pratibha C B

St Johns Medical College Hospital

cb.pratibha@gmail.com9986075682

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026