Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054769
Status:
COMPLETED
Last Update Posted:
2008-09-17
First Post:
2003-02-10
Brief Title:
Diagnosing Tuberculosis in HIV Infected Children in Peru
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Diagnostics For AIDS-Related Pediatric TB Peru
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None