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Trial record 41 of 53 for:    "Cryptococcosis"

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

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ClinicalTrials.gov Identifier: NCT02098525
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : March 28, 2014
Sponsor:
Information provided by (Responsible Party):
Punnee Pitisuttithum, Mahidol University

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.

Condition or disease
Cryptococcal Meningitis HIV/AIDS

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 195 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Outcomes of Cryptococcal Meningitis Among HIV-infected Patients in the Era of Antiretroviral Therapy
Study Start Date : November 2013
Actual Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Meningitis

Group/Cohort
HIV associated CM patients
The study population is all adult HIV positive patients with CM at Ramathibodi Hospital.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population is all adult HIV positive patients with CM at Ramathibodi Hospital, Mahidol University.
Criteria

Inclusion Criteria:

  • HIV-infected patients diagnosed by positive results of 2 different ELISA tests, 1 ELISA test accompanied with 1 HIV-PCR test, or 1 ELISA test accompanied with 1 Western blot test, whose age was more than 15 years old.
  • Newly diagnosed CM during the study period defined by positive culture, positive Indian ink or positive latex agglutination test on CSF with typical symptoms at Ramathibodi Hospital.

Exclusion Criteria:

  • Patients who had other known CNS co-infection or other significant concurrent CNS diseases which might influence on outcome of CM.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098525


Locations
Thailand
Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Taiichiro Kobayashi, Dr Mahidol University
Study Director: Punnee Pitisuttithum, Prof. Mahidol University
Study Chair: Weerawat Manosuthi, Dr. Bamrasnaradura infectious disease hospital

Responsible Party: Punnee Pitisuttithum, Prof., Mahidol University
ClinicalTrials.gov Identifier: NCT02098525     History of Changes
Other Study ID Numbers: HIVCM-01
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: March 28, 2014
Last Verified: March 2014

Keywords provided by Punnee Pitisuttithum, Mahidol University:
Cryptococcal meningitis
HIV/AIDS
Antiretroviral therapy
Prognosis
Thailand

Additional relevant MeSH terms:
Meningitis
Meningitis, Cryptococcal
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Fungal
Central Nervous System Fungal Infections
Mycoses
Cryptococcosis
Central Nervous System Infections