Status:
COMPLETED
Validation of a Tuberculosis Treatment Decision Algorithm in HIV-infected Children (TB-Speed HIV)
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsors:
UNITAID
Conditions:
Tuberculosis
HIV
Eligibility:
All Genders
1-14 years
Phase:
NA
Brief Summary
TB-Speed HIV is a prospective multicentre management study evaluating the safety and feasibility of the recently proposed PAANTHER TB treatment decision algorithm for HIV-infected children with presum...
Detailed Description
The ANRS 12229 PAANTHER 01 (Pediatric Asian African Network for Tuberculosis and HIV Research) study, which enrolled 438 HIV-infected children of median age 7.3 (IQR: 3.3 - 9.7) years with presumptive...
Eligibility Criteria
Inclusion
- Children aged 1 month to 14 years
- Documented HIV-infection (i.e., confirmed before entry into the study)
- Presumptive TB based on at least one criteria among the following:
- Persistent cough for more than 2 weeks
- Persistent fever for more than 2 weeks
- Recent failure to thrive (documented clear deviation from a previous growth trajectory in the last 3 months or Z score weight/age \< 2)
- Failure of broad spectrum antibiotics for treatment of pneumonia
- Suggestive CXR features
- OR
- History of contact with a TB case and any of the symptoms listed under point 3 with a shorter duration (\< 2 weeks)
- Informed consent signed by parent/guardian
Exclusion
- Ongoing TB treatment or history of intake of anti-TB drugs in the last 3 months (isoniazid alone or rifampin/isoniazid for preventive therapy is not an exclusion criteria)
Key Trial Info
Start Date :
October 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2022
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT04121026
Start Date
October 2 2019
End Date
June 20 2022
Last Update
March 28 2025
Active Locations (7)
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1
Cocody University Teaching Hospital
Abidjan, Côte d’Ivoire
2
Treichville University Teaching Hospital
Abidjan, Côte d’Ivoire
3
José Macamo General Hospital
Maputo, Mozambique
4
Maputo Central Hospital
Maputo, Mozambique