Diagnosing Tuberculosis in HIV Infected Children in Peru
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|ClinicalTrials.gov Identifier: NCT00054769|
Recruitment Status : Completed
First Posted : February 11, 2003
Last Update Posted : September 17, 2008
|Condition or disease|
|Tuberculosis Tuberculosis, Pulmonary HIV Infections|
HIV infection has been shown to increase mortality from tuberculosis (TB) fivefold in parts of Subsaharan Africa. Increasingly, HIV infected children in developing countries are becoming infected with Mycobacterium tuberculosis (Mtb) and dying at an early age. This project will evaluate novel approaches to the diagnosis of AIDS-related pediatric TB in a hyperendemic setting using rapid, cost-effective Mtb culture and susceptibility methods based on direct microscopic observation techniques. This study will utilize alternative noninvasive Mtb tests that are performed on nasopharyngeal aspirates (NPA) and stool. An optional component will assess improved rapid detection of Mtb by a semi-nested polymerase chain reaction assay (N2 PCR), a technique appropriate for regional reference laboratories in developing countries.
Two hundred-sixty children with clinically diagnosed pulmonary TB (including at least 100 HIV infected children) from the Hospital del Nino, Lima, Peru, and 260 age-matched controls will be enrolled in this study. Mtb will be detected in NPAs and stool by new and traditional culture methods and by N2 PCR. Gastric aspirates from children with a clinical diagnosis of TB will also be tested. Children with a positive N2 PCR but without clinical evidence of TB requiring antituberculous therapy will be followed longitudinally.
|Study Type :||Observational|
|Enrollment :||760 participants|
|Official Title:||Diagnostics For AIDS-Related Pediatric TB, Peru|
|Study Start Date :||March 2002|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||February 2007|
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): NCT00054769
|Instituto de Salud del Nino|
|Principal Investigator:||Richard A. Oberhelman, MD||Tulane School of Public Health and Tropical Medicine|