Paradoxical reactions in HIV associated cryptococcal meningitis - FISF Study
Not Applicable
- Conditions
- Health Condition 1: B20- Human immunodeficiency virus [HIV]disease
- Registration Number
- CTRI/2024/05/066747
- Lead Sponsor
- Fungal Infection Study Forum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of paradoxical reaction following anti fungal treatmentTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method •Determining clinical and laboratory features of PR in HIV CM <br/ ><br>•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. <br/ ><br>•CSF Opening pressure (OP), CSF CRP, CSF Lactate, White cells count, differential count, protein, glucose. <br/ ><br>•Any difference in PR after D-AmB therapy and L-AmB containing therapy. <br/ ><br>•Percentage of patients achieving sterile CSF culture after 1 and 2 weeks of antifungal therapy in HIV <br/ ><br>•To study cryptococcal species and its drug susceptibility in HIV associated CM <br/ ><br>•Species distributions and Drug susceptibility pattern and outcome at 8 and 12 weeks <br/ ><br>Timepoint: 12 weeks