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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05144763
Other study ID # 2020-02800
Secondary ID NIMR/HQ/R.8a/Vol
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date March 31, 2024

Study information

Verified date December 2023
Source Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Contact Valerie D'Acremont, PhD
Phone +41 61 284 8679
Email Valerie.DAcremont@unisante.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to reduce morbidity and mortality among children and mitigate antimicrobial resistance using a novel clinical decision support algorithm, enhanced with point-of-care technologies to help health workers in primary health care settings in Tanzania. Furthermore, the tool provides opportunities to improve supervision and mentorship of health workers and enhance disease surveillance and outbreak detection.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
ePOCT+
ePOCT+ is an electronic clinical decision support algorithm

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Sponsors (6)

Lead Sponsor Collaborator
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland Ecole Polytechnique Fédérale de Lausanne, Ifakara Health Institute, National Institute for Medical Research, Tanzania, Swiss Tropical & Public Health Institute, University of Geneva, Switzerland

Country where clinical trial is conducted

Tanzania, 

References & Publications (8)

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Outcome

Type Measure Description Time frame Safety issue
Other Change in percent of cases managed using ePOCT+ (uptake) over time Change in the percent of cases fully managed using ePOCT+ meaning that the medications and referral steps completed and case closed by healthcare worker. This outcome will be assessed month to month in the intervention arm only. Dated changes in implementation will be presented for context of temporal changes in outcome. through study 1 completion, thus 6 to 9 months
Other Change in the percent of children with basic anthropometrics and clinical signs assessed over time Change in the percent of children with anthropometric measurements (weight, height, MUAC) and clinical signs (respiratory rate) assessed and documented by the healthcare worker. This outcome will be assessed month to month in the intervention arm only. Dated changes in implementation will be presented for context of temporal changes in outcome. through study 1 completion, thus 6 to 9 months
Other Change in the percent of children with antibiotic prescribed over time Change in the percent of children with an antibiotic prescribed during initial consultation. This outcome will be compared between intervention and control arms month to month. Dated changes in implementation will be presented for context of temporal changes in outcome. through study 1 completion, thus 6 to 9 months
Primary Percentage of children cured at day 7 in the intervention group (ePOCT+) as compared to the control group (routine care) The child is defined as being cured at day 7 if the caregiver says that the child is cured or has improved since the initial consultation. Non-referred secondary hospitalizations (if caregiver says that child was hospitalized between day 0 and day 7 but the electronic clinical data does not indicate a referral for hospitalization) will however be considered as clinical failures even if the child is already cured at day 7. at day 7 (range 6-14) after enrollment
Primary Percentage of children prescribed an antibiotic at initial consultation in the intervention group (ePOCT+) as compared to the control group (routine care) Prescription of oral or parenteral antibiotic at initial consultation, as reported by the health care worker. by the end of the initial consultation (day 0)
Secondary Percentage of children with one or more unscheduled re-attendance visits at any health facility by day 7 Telephone or home visit follow-up 7 days (range 6-14 days) after enrollment of the subject. The day of enrollment of the subject is considered as day 0. by day 7 (range 6-14) after enrollment
Secondary Percentage of children with severe clinical outcome (death or non-referred secondary hospitalization) by day 7 Death and non-referred secondary hospitalization will be assessed by telephone or home visit follow-up 7 days (range 6-14 days) after enrollment of the subject. The day of enrollment of the subject is considered as day 0. by day 7 (range 6-14) after enrollment
Secondary Percentage of children referred to hospital or inpatient ward at a health centre at initial consultation Documented by the health care worker at the end of the initial consultation in the eCRF (control arm) or in ePOCT+ (intervention arm) when the subject was enrolled (day 0) by the end of the initial consultation (day 0)
Secondary Percentage of febrile children tested for malaria by RDT and/or microscopy at day 0 A febrile child is a child with a history of fever (measured or suspected fever in the past 48 hours) or a high temperature. by the end of the initial consultation (day 0)
Secondary Percentage of malaria positive children prescribed an antimalarial at day 0 An antimalarial prescription is any oral, rectal, intramuscular or intravenous antimalarial prescribed by a HCW during the initial consultation or a re-attendance visit. by the end of the initial consultation (day 0)
Secondary Percentage of malaria negative children prescribed an antimalarial at day 0 An antimalarial prescription is any oral, rectal, intramuscular or intravenous antimalarial prescribed by a HCW during the initial consultation or a re-attendance visit. by the end of the initial consultation (day 0)
Secondary Percentage of children untested for malaria prescribed an antimalarial at day 0 An antimalarial prescription is any oral, rectal, intramuscular or intravenous antimalarial prescribed by a HCW during the initial consultation or a re-attendance visit. by the end of the initial consultation (day 0)
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