Clinical Trial: Clinical Outcomes of Cryptococcal Meningitis Among HIV-infected Patients in the Era of Antiretroviral Therapy

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Clinical Outcomes of Cryptococcal Meningitis Among HIV-infected Patients in the Era of Antiretroviral Therapy

Brief Summary: Cryptococcal meningitis is one of the most common central nervous system infections among HIV-infected patients. The outcome is generally severe. This study aims to determine long-term survival rate among HIV-infected CM patients in the era of antiretroviral therapy (ART). The secondary objectives are to clarify outcomes of CM and determine prognostic factors.

Detailed Summary:

Study site:

The study are conducted at the Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.

Sample size calculation:

The sample size is obtained by using EPI Info program. Anticipated population proportion P which will be the major outcome of CM, the survival rate was 63% in Thailand (Chottanapund S, Singhasivanon P, Kaewkungwal J, Chamroonswasdi K, Manosuthi W. Survival time of HIV-infected patients with cryptococcal meningitis. J Med Assoc Thai. 2007 Oct;90(10):2104-11. PubMed PMID: 18041430). At the effect size of 80%, confidence level at 95% (P = 0.05), deviation error of allowanced of 5% and 210 expects HIV infected patients with CM during study period at Ramathibodi Hospital, the estimated sample size is 132 cases.

Outcome measurement:

Death case: Death case is CM patient who died for any reason during the period of follow-up.

Survival case: Survival case is CM patient who did not die during the period of follow-up.

Relapse case: This refers to a patient who developed a new episode of CM after clinical manifestations had disappeared and CSF culture had become negative, and confirmed by positive CSF culture for Cryptococcus neoformans.

IRIS case: This refers to a patient who developed a new episode of clinical meningitis after clinical manifestations stemming from a previous episode of CM had disappeared and the patient had been started ART, and defined as negative CSF culture for Cryptococcus neoformans. Alternative etiology which pre
Sponsor: Mahidol University

Current Primary Outcome: Long-term survival rate of CM [ Time Frame: Up to 12 years. Cases will be censored at the date of last visit if they are lost to follow up or referred to another hospital, and will be censored at the date of death. ]

To describe long-term survival rate of CM among adult HIV-infected patients in the era of ART.


Original Primary Outcome: Same as current

Current Secondary Outcome: Risk factors of short-term and long-term mortality of CM [ Time Frame: Up to 12 years. Cases will be censored at the date of last visit if they are lost to follow up or referred to another hospital, and will be censored at the date of death. ]

To identify risk factors of short-term and long-term mortality of CM.


Original Secondary Outcome: Same as current

Information By: Mahidol University

Dates:
Date Received: March 18, 2014
Date Started: November 2013
Date Completion:
Last Updated: March 27, 2014
Last Verified: March 2014