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Diagnosing Tuberculosis in HIV Infected Children in Peru

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00054769
First received: February 10, 2003
Last updated: September 16, 2008
Last verified: July 2007
History of Changes

February 10, 2003
September 16, 2008
March 2002
February 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00054769 on ClinicalTrials.gov Archive Site
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Diagnosing Tuberculosis in HIV Infected Children in Peru
Diagnostics For AIDS-Related Pediatric TB, Peru

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.

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.
Observational
Time Perspective: Prospective
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  • Tuberculosis
  • Tuberculosis, Pulmonary
  • HIV Infections
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Oberhelman RA, Soto-Castellares G, Gilman RH, Caviedes L, Castillo ME, Kolevic L, Del Pino T, Saito M, Salazar-Lindo E, Negron E, Montenegro S, Laguna-Torres VA, Moore DA, Evans CA. Diagnostic approaches for paediatric tuberculosis by use of different specimen types, culture methods, and PCR: a prospective case-control study. Lancet Infect Dis. 2010 Sep;10(9):612-20. Epub 2010 Jul 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
760
February 2007
February 2007   (final data collection date for primary outcome measure)

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
Both
up to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Peru
 
NCT00054769
1R01AI49139-01A1
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National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Richard A. Oberhelman, MD Tulane School of Public Health and Tropical Medicine
National Institute of Allergy and Infectious Diseases (NIAID)
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP