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Diagnosing Tuberculosis in HIV Infected Children in Peru

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054769
Recruitment Status : Completed
First Posted : February 11, 2003
Last Update Posted : September 17, 2008
Information provided by:
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.

Condition or disease
Tuberculosis Tuberculosis, Pulmonary HIV Infections

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.

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Study Type : Observational
Enrollment : 760 participants
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00054769

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Instituto de Salud del Nino
Lima, Peru
Sponsors and Collaborators
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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00054769    
Other Study ID Numbers: 1R01AI049139-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 11, 2003    Key Record Dates
Last Update Posted: September 17, 2008
Last Verified: July 2007
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Polymerase Chain Reaction
Additional relevant MeSH terms:
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Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections