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Trial record 26 of 68 for:    Diseases | ( Map: Mozambique )

TB-Speed Pneumonia

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ClinicalTrials.gov Identifier: NCT03831906
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
UNITAID
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary:

Despite progress in reducing tuberculosis (TB) incidence and mortality in the past 20 years, TB is a top ten cause of death in children under 5 years worldwide. However, childhood TB remains massively underreported and undiagnosed, mostly because of the challenges in confirming its diagnosis due to the paucibacillary nature of the disease and the difficulty in obtaining expectorated sputum in children.

Pneumonia is the leading cause of death in children under the age of 5 years worldwide. There is growing evidence that, in high TB burden settings, TB is common in children with pneumonia, with up to 23% of those admitted to hospital with an initial diagnosis of pneumonia later being diagnosed as TB. However, the current WHO standard of care (SOC) for young children with pneumonia considers a diagnosis of TB only if the child has a history of prolonged symptoms or fails to respond to antibiotic treatments. Hence, TB is often under-diagnosed or diagnosed late in children presenting with pneumonia.

In this context, the investigators are proposing to assess the impact on mortality of adding the systematic early detection of TB using Xpert MTB/RIF Ultra, performed on NPAs and stool samples, to the WHO SOC for children with severe pneumonia, followed by immediate initiation of anti-TB treatment in children testing positive on any of the samples.

TB-Speed Pneumonia is a multicentric, stepped wedge diagnostic trial conducted in six countries with high TB incidence: Cote d'Ivoire, Cameroon, Uganda, Mozambique, Zambia and Cambodia.


Condition or disease Intervention/treatment Phase
Tuberculosis Severe Pneumonia Diagnostic Test: Xpert MTB/RIF Ultra (Ultra) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3780 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

The TB-Speed Pneumonia study is a stepped wedge cluster-randomised trial. Clusters, i.e.hospitals, will successively switch from control to intervention in an order randomly assigned, until all clusters are eventually exposed to the intervention.

The TB-Speed Pneumonia study will be implemented in 15 hospitals. At the start of the study, all hospital will be implementing the WHO SOC for severe pneumonia (control arm). One hospital will then switch to the TB-Speed strategy (intervention arm) every 5 weeks.

Randomisation will be stratified on the country estimated TB incidence rate (see Table 3): <300/100,000 patients-years (Cameroon, Cote d'Ivoire and Uganda) vs. ≥300/100,000 patients-years (Cambodia, Mozambique and Zambia).

Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of Systematic Early Tuberculosis (TB) Detection Using Xpert MTB/RIF Ultra in Children With Severe Pneumonia in High Tuberculosis Burden Countries
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : December 23, 2020
Estimated Study Completion Date : December 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control

All children admitted in the hospital and presenting with WHO-defined severe pneumonia will be immediately managed as part of routine care per the WHO Standard of Care (SOC), including broad spectrum antibiotics, oxygen therapy if required, additional supportive care and specific therapies for comorbidities such as HIV infection.

For research purposes, children will benefit from HIV testing, malaria testing, and complete blood count (CBC) if not systematically performed as routine care in the country/hospital, as well as from a digitalized chest X-ray (CXR). Additionally, samples will be collected for future biomarkers studies (biobank).

Experimental: Interventional
Children will benefit from the WHO SOC and additional strategies for research purposes (HIV and malaria testing, CBC, CXR, and biobank) as described in the control arm, plus the study intervention.
Diagnostic Test: Xpert MTB/RIF Ultra (Ultra)

The intervention will consist of the WHO standard of care for children with severe pneumonia plus the study intervention consisting in rapid detection of TB on the day of hospital admission using the Ultra assay performed on 1 NPA and 1 stool sample.

The sample flow will be organised to reduce time-to-results to 3 hours. Ultra will be performed at the hospital laboratory using a standard GeneXpert device, or implemented directly inward using a one-module, battery-operated GeneXpert device (G1 Edge).

Drugs will be available at the inpatient level to enable immediate initiation of TB treatment, as soon as a positive Ultra result is available.





Primary Outcome Measures :
  1. All-cause mortality 12 weeks after inclusion [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Number of children diagnosed with TB at 12 weeks [ Time Frame: 12 weeks ]

    • Number of children diagnosed with TB at 12 weeks:

    • based on Ultra results
    • based on the clinician's judgement

  2. • Proportion of children with TB treatment initiated at any time during follow-up [ Time Frame: 12 weeks ]
  3. • Time to TB treatment initiation [ Time Frame: 12 weeks ]
  4. • Duration of TB treatment at end of trial [ Time Frame: 12 weeks ]
    • Duration of TB treatment at end of trial, i.e. week 12 or early termination

  5. • Number of inpatient deaths [ Time Frame: 12 weeks ]
  6. • Duration of initial hospitalization [ Time Frame: 12 weeks ]
  7. • Number of readmissions following discharge • Weight gain at 12 weeks (as compared to body weight at inclusion) [ Time Frame: 12 weeks ]
  8. • Weight gain at 12 weeks [ Time Frame: 12 weeks ]
    • Weight gain at 12 weeks, as compared to body weight at inclusion

  9. • Proportion of NPA and stool samples with positive TB detection using Ultra• [ Time Frame: 12 weeks ]
    In the intervention arm only.

  10. • Proportion of Ultra-confirmed and clinically-diagnosed TB cases [ Time Frame: 12 weeks ]
    In the intervention arm only.

  11. • Feasibility of NPA and stool samples collection (1) [ Time Frame: 12 weeks ]
    In the intervention arm only. Proportion of children with samples collected as per protocol

  12. • Feasibility of NPA and stool samples collection (2) [ Time Frame: 12 weeks ]
    In the intervention arm only. Turnaround time between NPA or stool sample collection and result of Ultra

  13. • Safety of NPA collection [ Time Frame: 12 weeks ]
    In the intervention arm only. Adverse events collected by study nurses during NPA collection such as vomiting, nose bleeding, low oxygen saturation

  14. • Tolerability of NPA specimen collection procedures assessed by the child [ Time Frame: real time ]
    In the intervention arm only. Discomfort/pain/distress experienced by the child assessed by the child him/herself (Wong-Baker face scale)

  15. • Tolerability of NPA specimen collection procedures assessed by the parents [ Time Frame: real time ]
    In the intervention arm only. Discomfort/pain/distress experienced by the child assessed by the parents (visual analog scale)

  16. • Tolerability of NPA specimen collection procedures assessed by the nurses [ Time Frame: real time ]
    In the intervention arm only. Discomfort/pain/distress experienced by the child assessed by the nurses (FLACC behavioural scale)

  17. • Acceptability of NPA and stool specimen collection procedures [ Time Frame: real time ]

    In the intervention arm only.

    • Acceptability of NPA and stool specimen collection procedures assessed by parents and nurses (semi-structured interviews and auto-questionnaires).



Other Outcome Measures:
  1. Comparison of the cost-effectiveness of the two strategies [ Time Frame: 12 weeks ]
    Incremental cost-effectiveness ratio (ICER)



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Children aged 2 to 59 months
  2. Newly hospitalized for severe pneumonia defined using WHO criteria as cough or difficulty in breathing with:

    1. Peripheral oxygen saturation < 90% or central cyanosis, or
    2. Severe respiratory distress (e.g. grunting, nasal flaring, very severe chest indrawing), or
    3. Signs of pneumonia, defined as cough or difficulty in breathing with fast breathing (tachypnea) and/or chest indrawing, with any of the following danger signs:

      • Inability to breastfeed or drink,
      • Persistent vomiting
      • Lethargy or reduced level of consciousness
      • Convulsions,
      • Stridor in calm child
      • Severe malnutrition
  3. Informed consent signed by parent/guardian

Exclusion criteria:

- Ongoing TB treatment or history of intake of anti-TB drugs in the last 6 months


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831906


Contacts
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Contact: Aurelia Vessiere, PhD +33 (0)5 57 57 15 35 aurelia.vessiere@u-bordeaux.fr
Contact: Angeline Serre, PhD +33 (0)5 57 57 47 18 angeline.serre@u-bordeaux.fr

Locations
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Cambodia
Kampong Cham Provincial Referral Hospital Recruiting
Kampong Cham, Cambodia
Contact: Country Principal Investigator       lborand@pasteur-kh.org   
Contact: Country co-PI       mao@online.com.kh   
National Pediatric Hospital Recruiting
Phnom Penh, Cambodia
Contact: Country Principal Investigator       lborand@pasteur-kh.org   
Contact: Country co-PI       mao@online.com.kh   
Takeo Provincial Referral Hospital Recruiting
Takeo, Cambodia
Contact: Country Principal Investigator       lborand@pasteur-kh.org   
Contact: Country co-PI       mao@online.com.kh   
Cameroon
Biyem Assi District Hospital Recruiting
Yaoundé, Cameroon
Contact: Country Principal Investigator       maryline.bonnet@ird.fr   
Contact: Country co-PI       jvoisintag@yahoo.fr   
Chantal Biya Foundation Recruiting
Yaoundé, Cameroon
Contact: Country Principal Investigator       maryline.bonnet@ird.fr   
Contact: Country co-PI       jvoisintag@yahoo.fr   
Côte D'Ivoire
Cocody University Teaching Hospital Recruiting
Abidjan, Côte D'Ivoire
Contact: Country Principal Investigator       raoul.moh@pacci.ci   
Contact: Country co-PI       koflaur@hotmail.com   
Treichville University Teaching Hospital Recruiting
Abidjan, Côte D'Ivoire
Contact: Country Principal Investigator       raoul.moh@pacci.ci   
Contact: Country co-PI       koflaur@hotmail.com   
Yopougon University Teaching Hospital Recruiting
Abidjan, Côte D'Ivoire
Contact: Country Principal Investigator       raoul.moh@pacci.ci   
Contact: Country co-PI       koflaur@hotmail.com   
Mozambique
José Macamo General Hospital Recruiting
Maputo, Mozambique
Contact: Country Principal Investigator       khosacelso@gmail.com   
Contact: Country co-PI       mavale23@yahoo.co.uk   
Maputo Central Hospital Recruiting
Maputo, Mozambique
Contact: Country Principal Investigator       khosacelso@gmail.com   
Contact: Country co-PI       mavale23@yahoo.co.uk   
Uganda
Jinja Regional Reference Hospital Recruiting
Jinja, Uganda
Contact: Country Principal Investigator       ewobudeya@mujhu.org   
Contact: Country co-PI       Juliet.MWANGA@epicentre.msf.org   
Mulago National Referral Hospital Recruiting
Kampala, Uganda
Contact: Country Principal Investigator       ewobudeya@mujhu.org   
Contact: Country co-PI       Juliet.MWANGA@epicentre.msf.org   
Holy Innocents Children's Hospital Recruiting
Mbarara, Uganda
Contact: Country Principal Investigator       ewobudeya@mujhu.org   
Contact: Country co-PI       Juliet.MWANGA@epicentre.msf.org   
Zambia
Lusaka University Teaching Hospital Recruiting
Lusaka, Zambia
Contact: Country Principal Investigator       cchabala@gmail.com   
Contact: Country co-PI       veromulenga@gmail.com   
Arthur Davidson Children Hospital Recruiting
Ndola, Zambia
Contact: Country Principal Investigator       cchabala@gmail.com   
Contact: Country co-PI       veromulenga@gmail.com   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
UNITAID
Investigators
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Principal Investigator: 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

Additional Information:
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03831906     History of Changes
Other Study ID Numbers: C18-26
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tuberculosis
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections