HIV/AIDS Clinical Trial
Official title:
Clinical Outcomes of Cryptococcal Meningitis Among HIV-infected Patients in the Era of Antiretroviral Therapy
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.
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 presents symptoms similar to CM must be ruled out.
Clinical outcome parameters:
Short-term outcome: Short-term outcome is defined as the outcome that happened within 1 year
of follow up period.
Long-term outcome: Long-term outcome is defined as all outcomes that happened after 1 year
of follow up period.
Margin period to evaluate the blood findings at AmB induction therapy initiation is defined
as within 3 months from the exact date of AmB induction therapy initiation.
Margin period to evaluate the parameters at AmB induction therapy completion is defined as
within 7 days from the exact date of AmB induction therapy completion.
Margin period to evaluate the CSF findings at ART initiation is defined as within 1 month
from the exact date of ART initiation.
Margin period to evaluate the blood findings at ART initiation is defined as from 3 months
before to 1 month after the exact date of ART initiation.
Margin period to evaluate the parameters at secondary FLCZ prophylaxis completion is defined
as within 3 months from the exact date of secondary FLCZ prophylaxis completion.
Research methodology:
The medical records of those diagnosed with HIV associated CM is retrieved from the medical
record department in Ramathibodi Hospital. Then the inclusion and exclusion criteria are
checked. We review at least 132 cases. The information from the medical records which pass
the criteria is extracted and transferred to the case report form. Then data entry is
carried out with coding and verified.
Statistical analysis:
The data will be computed by means of the descriptive statistical methods as the following
values: frequency distribution, proportion, rate, median and range. To compare demographic
and clinical characteristics, we will use chi-square tests or Fisher's exact tests for
categorical variables and student's t tests or Mann-Whitney U tests for continuous
variables. Cox's proportional hazards model and Kaplan-Meier survival analysis will be used
to evaluate factors associated with outcomes. Hazard ratio, odds ratio and 95% CI will be
calculated and used as a measure of the strength of the association between the outcome
variables and their predictors. A two-tailed alpha level of 0.05 will be used to determine
statistical significance. Statistical analyses will be performed with the statistical
program, SPSS.
Ethical committee approval:
As a retrospective study, we review patients' medical records only. No patient are directly
involved in this study and therefore no informed consent is obtained. The proposal is
reviewed by the Ethical Committee of the Faculty of Tropical Medicine, Mahidol University,
for clearance. Data collection was started after the protocol is ethically approved.
Confidentiality:
The names or any clues leading to the identification of the patients are not be recorded in
CRF (case record form). Only code numbers are recorded in CRF. The information of patient's
identification and code number are kept separately. The results are presented as medical
data with no personal identifying information. Authorized person helps to collect data.
Research funds:
Funding for the study is provided by the Faculty of Tropical Medicine, Mahidol University,
Bangkok, Thailand.
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Observational Model: Cohort, Time Perspective: Retrospective
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