Tuberculosis Clinical Trial
— INPUTOfficial title:
Integrating Pediatric TB Services Into Child Healthcare Services in Africa. A Cluster-randomized Stepped-wedge Trial
NCT number | NCT03862261 |
Other study ID # | EG0214 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 10, 2019 |
Est. completion date | December 31, 2021 |
Verified date | March 2022 |
Source | Elizabeth Glaser Pediatric AIDS Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Under-diagnosis of TB in children is a critical gap to address. The INPUT study is a multinational stepped-wedge cluster-randomized intervention study aiming to assess the effect of integrating TB services into child healthcare services on TB diagnosis capacities in children under 5 years of age.
Status | Completed |
Enrollment | 1715 |
Est. completion date | December 31, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 5 Years |
Eligibility | Inclusion Criteria: - Children < 5 years old. - TB diagnosis investigations initiated. - Other infectious diseases are not suspected or have already been ruled out. - Commitment to take treatment in the clinic of enrolment or another INPUT study site. - Parental/caregiver consent for the child to participate in the study. Exclusion Criteria: - Children who are TB contacts but without symptoms or signs of active TB |
Country | Name | City | State |
---|---|---|---|
Cameroon | Hopital de District Akonolinga | Akonolinga | Centre |
Cameroon | Hopital de District Dschang | Dschang | West |
Cameroon | Hopital de District Loum | Loum | Littoral |
Cameroon | Hopital de District Foumban | Mbanga | Littoral |
Cameroon | Hopital de District Mbouda | Mbouda | West |
Cameroon | Hopital de District Soa | Soa | Centre |
Kenya | Homa Bay County Referral Hospital | Homa Bay | |
Kenya | Kakuma Mission Hospital | Kakuma | Turkana |
Kenya | Kendu Sub County Hospital | Kendu Bay | Homa Bay |
Kenya | Lokitaung sub-county hospital | Lokitaung | Turkana |
Kenya | Lopiding Sub County Hospital | Lopiding | Turkana |
Kenya | Ndhiwa Sub county Hospital | Ndhiwa | Homa Bay |
Lead Sponsor | Collaborator |
---|---|
Elizabeth Glaser Pediatric AIDS Foundation | Cameroon Ministry of Public Health, Kenya Ministry of Health, UNITAID, University of Sheffield |
Cameroon, Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of children diagnosed with active TB | Number of pediatric TB cases diagnosed (bacteriologically confirmed and/or clinically diagnosed) over the number of children attending the child healthcare services during the study period. | up to two months | |
Secondary | Proportion of children screened for TB | Number of children screened for TB over the number of children attending the child healthcare services during the study period | one month | |
Secondary | Proportion of screened children who have a sample collected | Proportion of children who have a sample collected for microbiologic diagnosis among those screened positive for TB (i.e. presumptive TB cases) | up to three months | |
Secondary | Proportion of children diagnosed with TB among presumptive TB cases | Proportion of children diagnosed with TB (bacteriologically or clinically) among presumptive TB cases, overall and disaggregated by HIV status and nutrition status | up to two months | |
Secondary | Time from screening to clinical or bacteriologic diagnosis | For children finally diagnosed with TB, time elapsed from presumptive to confirmed TB case | up to three months | |
Secondary | Time from diagnosis to treatment initiation | For children diagnosed with TB, time elapsed to initiate treatment after active TB is confirmed | up to three months | |
Secondary | Proportion of cases with a bacteriologically confirmed diagnosis | Proportion of cases with a bacteriologically confirmed diagnosis among children diagnosed with TB | up to three months | |
Secondary | Proportion of children who initiate TB treatment among those diagnosed | Proportion of children who initiate TB treatment among those diagnosed will give treatment coverage | up to two months | |
Secondary | Treatment outcome | Treatment outcomes for patients initiated on treatment according to WHO categories: treatment success, treatment failed, died, lost to follow-up, and not evaluated. | 8 to 14 months (2 months after treatment completion) | |
Secondary | Adherence to the TB treatment | Adherence documented by seven-day recall and counting of pills | 6 to 12 months (at treatment completion) |
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