Diagnosing Tuberculosis in HIV Infected Children in Peru
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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.
Condition |
---|
Tuberculosis Tuberculosis, Pulmonary HIV Infections |
Study Type: | Observational |
Study Design: | Time Perspective: Prospective |
Official Title: | Diagnostics For AIDS-Related Pediatric TB, Peru |
Estimated Enrollment: | 760 |
Study Start Date: | March 2002 |
Study Completion Date: | February 2007 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | up to 12 Years |
Genders Eligible for Study: | Both |
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
No publications provided by National Institute of Allergy and Infectious Diseases (NIAID)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00054769 History of Changes |
Other Study ID Numbers: | 1R01AI49139-01A1 |
Study First Received: | February 10, 2003 |
Last Updated: | September 16, 2008 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Pediatrics Polymerase Chain Reaction |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Tuberculosis Tuberculosis, Pulmonary Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on March 03, 2013