Clinical Effectiveness and Safety of Amphotericin B With Flucytosine-Fluconazole Therapy for Cryptococcal Meningitis

NCT04532463 | Completed DMC

• 1 other identifier: 122020
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To study the clinical effectiveness and safety of amphotericin B with flucytosine-fluconazole therapy for cryptococcal meningitis in patients with HIV infection.

Conditions

Cryptococcal Meningitis

Outcome Measures

Primary Outcomes (2)

• Clinical effectiveness

  1. To describe the clinical effectiveness of amphotericin B with flucytosine-fluconazole combination therapy by assessing clinical parameters (presence of headache, fever, convulsion, abnormal mental status and death) at day 1, day 7 and day 14 2. To determine the severity of headache before and after treatment by numerical rating scale

  14 days (day1 to day 14)

• Clinical safety

  3\. . To describe the clinical safety of amphotericin B with flucytosine-fluconazole combination therapy by assessing hematological and biochemical parameters (hemoglobin, neutrophil, platelet, ALT, AST, serum creatinine and serum potassium level ) by DAIDS grading at baseline, day 7 and day 14

  14 days (day1 to day 14)

Secondary Outcomes (1)

• back-ground characteristics of patients

  14 days (day1 to day 14)

Study Arms (1)

Amphotericin B,Flucytosine, Fluconazole

Amphotericin B 1 mg/kg 1 week \& Flucytosine 100 mg/kg 1 week followed by Fluconazole 1200 mg/day 1 week

Drug: Amphotericin B 1 mg/kg 1 week & Flucytosine 100 mg/kg 1 week followed by Fluconazole 1200 mg/day 1 week

Interventions

Amphotericin B 1 mg/kg 1 week & Flucytosine 100 mg/kg 1 week followed by Fluconazole 1200 mg/day 1 week DRUG

To study the clinical effectiveness and safety of amphotericin B with flucytosine-fluconazole therapy for cryptococcal meningitis in patients with HIV infection.

Amphotericin B,Flucytosine, Fluconazole

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to SHW, SHM, SHT, YGH, NOGTH and IGH with HIV-associated cryptococcal meningitis who will be treated with amphotericin + flucytosine + fluconazole induction regimen.

You may qualify if:

• Patients with HIV-associated cryptococcal meningitis, admitted to inpatient department of SHW, SHM, SHT, YGH, NOGTH and IGH during the study period
• Patients of both sexes
• Age above 14 years
• Patients or caregivers who will give informed consent to participate in this study

Sponsors & Collaborators

• University of Pharmacy, Yangon: lead

Study Sites (1)

Specialist hospital Mingalardon,Thakeyta and Waibargi,Yangon General Hospital,Insein General Hospital, North Oakalapa General and Teaching Hosptial

Yangon, 11181, Burma

Location

MeSH Terms

Conditions

Meningitis, Cryptococcal

Interventions

Amphotericin B; Flucytosine

Condition Hierarchy (Ancestors)

Meningitis, Fungal; Central Nervous System Fungal Infections; Mycoses; Bacterial Infections and Mycoses; Infections; Cryptococcosis; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Cytosine; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• zin win may, B.Pharm

  Specialist Hospital Thakeyta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical effectiveness and safety of Amphotericin B with Flucytosine-Fluconazole therapy for Cryptococcal meningitis in patients with HIV infection

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 31, 2020
• Study Start: October 1, 2020
• Primary Completion: March 30, 2022
• Study Completion: April 20, 2022
• Last Updated: April 21, 2022

Record last verified: 2022-04

Locations

BU (1)