Diagnosing Tuberculosis in HIV Infected Children in Peru

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

760 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-03-31

Study Completion Date

2007-02-28

Brief Summary

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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

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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.

Conditions

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Tuberculosis Tuberculosis, Pulmonary HIV Infections

Keywords

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Pediatrics Polymerase Chain Reaction

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Richard A. Oberhelman, MD

Role: PRINCIPAL_INVESTIGATOR

Tulane School of Public Health and Tropical Medicine

Locations

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Instituto de Salud del Nino

Lima, Lima Province, Peru

Site Status

Countries

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Peru

References

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Oberhelman RA, Soto-Castellares G, Gilman RH, Castillo ME, Kolevic L, Delpino T, Saito M, Salazar-Lindo E, Negron E, Montenegro S, Laguna-Torres VA, Maurtua-Neumann P, Datta S, Evans CA. A Controlled Study of Tuberculosis Diagnosis in HIV-Infected and Uninfected Children in Peru. PLoS One. 2015 Apr 30;10(4):e0120915. doi: 10.1371/journal.pone.0120915. eCollection 2015.

Reference Type DERIVED

PMID: 25927526 (View on PubMed)

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. doi: 10.1016/S1473-3099(10)70141-9. Epub 2010 Jul 23.

Reference Type DERIVED

PMID: 20656559 (View on PubMed)

Other Identifiers

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1R01AI049139-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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