Clinical Trial: Diagnosing Tuberculosis in HIV Infected Children in Peru

This study is currently recruiting patients.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

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.

Condition
Tuberculosis
Tuberculosis, Pulmonary
HIV Infections

MedlinePlus related topics:  AIDS;   Respiratory Diseases;   Tuberculosis

Study Type: Observational
Study Design: Screening, Cross-Sectional, Case Control, Prospective Study

Official Title: Diagnostics For AIDS-Related Pediatric TB, Peru

Further Study Details: 

Expected Total Enrollment:  600

Study start: March 2002

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.

Eligibility

Ages Eligible for Study:  up to  12 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

Location and Contact Information


Peru
      Instituto de Salud del Nino, Lima,  Peru; Recruiting
Maria E. Castillo, MD  011-511-424-1996    dianajose@infonegocio.net.pe 
Maria E. Castillo, MD,  Sub-Investigator

Study chairs or principal investigators

Richard A. Oberhelman, MD,  Principal Investigator,  Tulane School of Public Health and Tropical Medicine   

More Information

Study ID Numbers:  1R01AI49139-01A1
Record last reviewed:  November 2004
Last Updated:  November 24, 2004
Record first received:  February 10, 2003
ClinicalTrials.gov Identifier:  NCT00054769
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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