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

NCT04121026 | Completed DMC

• 1 other identifier: C18-27
• Study Type: interventional
• Target: 278
• Locations: 4 countries
• Sites: 7

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 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.

Conditions

Tuberculosis; HIV

Keywords

Tuberculosis; Diagnosis; HIV; Child

Outcome Measures

Primary Outcomes (1)

• Proportion of missed TB cases

  Proportion of missed TB cases (false negative cases) in children not initiated on treatment as per the PAANTHER TB treatment decision algorithm

  6 months

Secondary Outcomes (20)

• Feasibility of the PAANTHER TB treatment decision algorithm (a): Proportion of children with presumptive TB having completed the algorithm.

  6 months

• Feasibility of the PAANTHER TB treatment decision algorithm (b): Time to final TB treatment decision

  6 months

• Proportion of HIV-infected children with unlikely TB among those initiated on treatment as per the PAANTHER TB treatment decision algorithm

  6 months

• Incidence of morbidity

  6 months

• Incidence of mortality

  6 months

Other Outcomes (1)

• Incremental cost-effectiveness ratio (ICER)

  33 months

Interventions

External validation of the PAANTHER TB treatment decision algorithm OTHER

The PAANTHER algorithm will be used for a TB treatment decision by site clinicians in all children enrolled in the study. The PAANTHER algorithm and prediction score was designed as a guiding tool for empirical TB treatment decision in HIV-infected children with presumptive TB. The proposed score includes: * history of contact * suggestive TB symptoms * tachycardia * chest radiography * abdominal ultrasound * Xpert MTB/RIF Ultra. A score of \>100 is highly predictive of TB. In children with a score \>100, anti-TB treatment will be initiated immediately. In children with a score of \<100, TB treatment will not be initiated except in those with severe/life-threatening conditions for whom TB treatment decision could be made at the discretion of the site clinician. TB could be definitely ruled out after further assessment and decision made as to what treatment the children should receive in accordance with existing national protocols, along with clinical follow-up.

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• UNITAID: collaborator

Study Sites (7)

Cocody University Teaching Hospital

Abidjan, Côte d’Ivoire

Location

Treichville University Teaching Hospital

Abidjan, Côte d’Ivoire

Location

José Macamo General Hospital

Maputo, Mozambique

Location

Maputo Central Hospital

Maputo, Mozambique

Location

Mbarara Regional Hospital

Mbarara, Uganda

Location

Lusaka University Teaching Hospital

Lusaka, Zambia

Location

Arthur Davidson Children Hospital

Ndola, Zambia

Location

Related Links

• TB-Speed project official website

MeSH Terms

Conditions

Tuberculosis; Disease

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier Marcy, MD, PhD

  University of Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Maryline Bonnet, MD, PhD

  Institut de Recherche pour le Développemnt (IRD) Montpellier, France

  PRINCIPAL INVESTIGATOR

• Eric Wobudeya, MD, PhD

  MU-JHU Care Ltd, Kampala, Uganda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 9, 2019
• Study Start: October 2, 2019
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: March 28, 2025

Record last verified: 2025-02

Locations

MO (2); CÔ (2); UG (1); ZA (2)