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Paradoxical reactions in HIV associated cryptococcal meningitis - FISF Study

Incidence of paradoxical reaction following antifungal treatment in HIV associated cryptococcal meningitis (CM) in India; a FISF multicenter prospective study. - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/05/066747
Enrollment
200
Registered
2024-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: B20- Human immunodeficiency virus [HIV]disease

Interventions

None listed

Sponsors

Fungal Infection Study Forum
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Adult HIV infected patients with age more than 18 years with first episode of CM • Diagnosis of CM arrived by CSF Cryptococcal Antigen (CrAg) Positive or Cryptococcal culture positive

Exclusion criteria

Exclusion criteria: 1. Patient receiving Antiretroviral treatment. 2. Pregnancy. 3. History of cryptococcal meningitis in the past, recurrence of CM 4. Patients with other co-infections (tuberculous meningitis, varicella zoster/herpes meningo-encephalitis, neurosyphilis, toxoplasmosis) 5. Not willing to participate or refuse consent.

Design outcomes

Primary

MeasureTime frame
Incidence of paradoxical reaction following anti fungal treatmentTimepoint: 12 weeks

Secondary

MeasureTime frame
• Determining clinical and laboratory features of PR in HIV CM • Compare changes in the various inflammatory markers in the CSF (local inflammation) and serum (Systemic inflammation) at baseline, day 7 and 14 after antifungal treatment in patients with and without PR and outcome. • CSF Opening pressure (OP), CSF CRP, CSF Lactate, White cells count, differential count, protein, glucose. • Any difference in PR after D-AmB therapy and L-AmB containing therapy. • Percentage of patients achieving sterile CSF culture after 1 and 2 weeks of antifungal therapy in HIV • To study cryptococcal species and its drug susceptibility in HIV associated CM • Species distributions and Drug susceptibility pattern and outcome at 8 and 12 weeks Timepoint: 12 weeks

Countries

India

Contacts

Public ContactAtul Patel

Sterling Hospitals

atulpatel65@gmail.com07926440816

Outcome results

None listed

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