Diagnosing Tuberculosis in HIV Infected Children in Peru

HIV Infections Clinical Trial

Official title:

Diagnostics For AIDS-Related Pediatric TB, Peru

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054769
• Other study ID #: 1R01AI049139-01A1
• Status: Completed
• Phase: N/A
• First received: February 10, 2003
• Last updated: September 16, 2008
• Start date: March 2002
• Est. completion date: February 2007

Study information

• Verified date: July 2007
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 760
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria

• Inability to produce sputum sample

• Clinical picture suggestive of pulmonary TB, score > 7 according to the Stegen and Toledo criteria as adapted by WHO

Exclusion Criteria

• Antituberculous therapy

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections
• Tuberculosis
• Tuberculosis, Pulmonary

Locations

Country	Name	City	State
Peru	Instituto de Salud del Nino	Lima

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Peru,