TuberculosisNCT00054769
Diagnosing Tuberculosis in HIV Infected Children in Peru
An observational study of Tuberculosis and Tuberculosis, Pulmonary, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Tuberculosis, Pulmonary, HIV Infections
- How many people
- 760 participants
- Where
- 1 sitePeru
- Study dates
- Mar 2002to Feb 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Inability to produce sputum sample
- Clinical picture suggestive of pulmonary TB, score > 7 according to the Stegen and Toledo criteria as adapted by WHO
Who cannot join
- Antituberculous therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, HIV Infections
- Keywords
- Pediatrics, Polymerase Chain Reaction
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary, HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2003 (estimated)
- Study startMar 2002
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 760 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Richard A. Oberhelman, MD, Principal investigator, Tulane School of Public Health and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054769
- Sponsor's protocol ID
- 1R01AI049139-01A1
- Status last verified
- Jul 2007
- First submitted
- 10 Feb 2003
- Last updated
- 17 Sep 2008
- Results posted
- No
Publications
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.
PubMed 25927526Oberhelman 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.
PubMed 20656559
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostics For AIDS-Related Pediatric TB, Peru
- ClinicalTrials.gov ID
- NCT00054769
- Acronym / sponsor ID
- 1R01AI049139-01A1
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, HIV Infections
- Keywords
- Pediatrics, Polymerase Chain Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 760 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2002
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 11 Feb 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Inability to produce sputum sample
- Clinical picture suggestive of pulmonary TB, score > 7 according to the Stegen and Toledo criteria as adapted by WHO
Key exclusion criteria (1 listed)
- Antituberculous therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2008.
- Derived from this study: PubMed 25927526Oberhelman 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.
- Derived from this study: PubMed 20656559Oberhelman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard A. Oberhelman, MD principal investigator
Tulane School of Public Health and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Tuberculosis, Pulmonary, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00054769, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2008.