CompletedNot Applicable

Validation of a Tuberculosis Treatment Decision Algorithm in HIV-infected Children (TB-Speed HIV)

Côte d’Ivoire, Mozambique, Uganda278 participantsStarted 2019-10-02

Plain-language 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 presumptive TB. It will be conducted in four countries with high and very high TB (Tuberculosis) incidence (Côte d'Ivoire, Uganda, Mozambique, and Zambia) which have not participated in the study that developed the PAANTHER algorithm.

Who can participate

Age range1 Month – 14 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

Proportion of missed TB cases

Timeframe: 6 months

Trial details

NCT IDNCT04121026

SponsorInstitut National de la Santé Et de la Recherche Médicale, France

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-06-20

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