Diagnosing Tuberculosis in HIV Infected Children in Peru

Completed

• Conditions: Tuberculosis; Tuberculosis, Pulmonary; HIV Infections

• Registration Number: NCT00054769
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

Tuberculosis is a major cause of mortality among AIDS patients in the developing world. The diagnosis of tuberculosis in HIV infected children is complicated by inefficient and expensive tuberculosis tests and vague diagnostic criteria. This study will evaluate the accuracy and efficiency of several different tuberculosis tests that could be used in developing countries.

Detailed Description

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 Timeline

• Study Start: 2002-03
• Study First Submitted: 2003-02-10
• Study First Submitted QC: 2003-02-10
• Study First Posted: 2003-02-11
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2007-07
• Last Update Submitted: 2008-09-16
• Last Update Posted: 2008-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 760

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Instituto de Salud del Nino; 🇵🇪 Lima, Peru