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

Sponsor

University of Pharmacy, Yangon (Other)

Overall Status

Completed

CT.gov ID

NCT04532463

Collaborator

(none)

Enrollment

Location

18.6

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cryptococcal Meningitis	Drug: Amphotericin B 1 mg/kg 1 week & Flucytosine 100 mg/kg 1 week followed by Fluconazole 1200 mg/day 1 week

Detailed Description

Cryptococcal meningitis is an AIDS-defining illness mostly caused by the fungus, Cryptococcus neoformans. In high-income countries, the use of amphotericin B in combination with a more expensive drug, flucytosine, is most effective for the management of cryptococcal meningitis; but access to flucytosine is severely limited in middle and low-income countries. In Myanmar, currently recommended regimen for cryptococcal meningitis are combination of amphotericin B with fluconazole. Although amphotericin plus flucytosine followed by fluconazole therapy is the currently preferred regimen in WHO treatment guidelines, it is not still commonly used in Myanmar clinical practice because of its limited availability. Therefore, the data regarding tolerability and clinical effectiveness of flucytosine are unavailable for Myanmar patients.

Although trials were carried out for investigating the effectiveness of flucytosine in the HIV population of Africa, the variability in drug response can occur in Myanmar patients due to the racial and genetic differences and whether it is effective and safe for Myanmar people is a great curiosity question for clinicians and healthcare workers. In Myanmar, amphotericin plus flucytosine followed by fluconazole regimen will be supplied by National AIDS Program (NAP) and indicated in 2020. Thus, the documents for effectiveness and safety profile need to be established. This is the reason that the effectiveness and safety of amphotericin B with flucytosine and fluconazole combination therapy should be studied. From this study, it can provide information to physicians regarding the effectiveness as well as safety of those drugs in the management of cryptococcal meningitis in HIV patients.

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Clinical Effectiveness and Safety of Amphotericin B With Flucytosine-Fluconazole Therapy for Cryptococcal Meningitis in Patients With HIV Infection

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Mar 30, 2022

Actual Study Completion Date :

Apr 20, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Clinical effectiveness [14 days (day1 to day 14)]
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 To determine the severity of headache before and after treatment by numerical rating scale
Clinical safety [14 days (day1 to day 14)]
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

Secondary Outcome Measures

back-ground characteristics of patients [14 days (day1 to day 14)]
4. To find out the back-ground characteristics of patients (age,gender) with HIV-associated cryptococcal meningitis

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Specialist hospital Mingalardon,Thakeyta and Waibargi,Yangon General Hospital,Insein General Hospital, North Oakalapa General and Teaching Hosptial	Yangon		Myanmar	11181

Sponsors and Collaborators

University of Pharmacy, Yangon

Investigators

Principal Investigator: zin win may, B.Pharm, Specialist Hospital Thakeyta

Study Documents (Full-Text)

Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jul 29, 2020

More Information

Publications

None provided.

Responsible Party:

Ms. Zin Win May, Principal Investigator, Clinical effectiveness and safety of Amphotericin B with Flucytosine-Fluconazole therapy for Cryptococcal meningitis in patients with HIV infection, University of Pharmacy, Yangon

ClinicalTrials.gov Identifier:

NCT04532463

Other Study ID Numbers: