Tuberculosis Clinical Trial
— TBcontactOfficial title:
Screening of Children in Household Contact With Adult TB Patients in Mbarara Hospital, Uganda: An Open Cohort of Children <5 Years in Contact With Newly Diagnosed Adult TB Cases in Mbarara Hospital
The proposed study aims to establish a pilot program through a prospective cohort study offering routine contact tracing, investigation and prophylaxis for LTBI, and treatment of TB disease to children <5 years living in the same household as adults diagnosed with smear/culture-positive pulmonary TB in Mbarara Regional Referral Hospital
Status | Completed |
Enrollment | 281 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 5 Years |
Eligibility |
Inclusion Criteria: - Any child who has lived in the same household with the index case continuously for at least 2 weeks within the 3-month period immediately preceding the diagnosis of smear- positive or culture-positive TB in the index case. - Informed consent signed by the parent or legal guardian - Living within a 2-hour radius of Mbarara town Exclusion Criteria: - Child currently receiving anti-tuberculosis treatment - Child has received a full course of anti-TB treatment within the last 6 months |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Epicentre | Mbarara University of Science and Technology, Medecins Sans Frontieres |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of <5 year-old child contacts classified as active TB disease, LTBI or no infection | Baseline | No | |
Secondary | Number of children <5 years exposed to TB in the household of adult index cases | Baseline | No | |
Secondary | Number of contacts identified as active TB basing on a symptom-based approach compared with those based on chest radiography | 9 months | No | |
Secondary | Proportion of contacts with HIV co-infection classified as non infected, LTBI or active TB | 9 months | No | |
Secondary | Median duration of exposure to symptomatic source case among the contacts in the various classes | Baseline | No | |
Secondary | Association of various risk factors with the final classification of contacts after assessment | 9 months | No | |
Secondary | Proportion of children with LTBI successfully treated (prevented from developing active TB disease) among HIV-infected and uninfected children | 9 months | No | |
Secondary | Proportion of children with no TB infection or disease successfully treated (prevented from developing active TB disease or LTBI) | 9 months | No | |
Secondary | Proportion of adverse events on treatment of TB disease, LTBI and TB exposure | 9 months | No | |
Secondary | Adherence to IPT regimens | 9 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05738681 -
Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial
|
Phase 2/Phase 3 | |
Recruiting |
NCT05526885 -
Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa
|
N/A | |
Completed |
NCT04369326 -
Community Initiated Preventive Therapy for TB
|
N/A | |
Recruiting |
NCT04568967 -
TB-CAPT EXULTANT - HIV
|
N/A | |
Completed |
NCT02337270 -
Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol
|
Phase 1 | |
Not yet recruiting |
NCT06253715 -
Shortened Regimen for Drug-susceptible TB in Children
|
Phase 3 | |
Recruiting |
NCT04271397 -
Immunological Biomarkers in Tuberculosis Management
|
N/A | |
Withdrawn |
NCT03639038 -
Tuberculosis Diagnosis by Flow Cytometry
|
||
Completed |
NCT03199313 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
|
Phase 1 | |
Recruiting |
NCT04975178 -
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
|
Phase 3 | |
Completed |
NCT04463680 -
Rifampin and the Contraceptive Implant
|
Phase 4 | |
Completed |
NCT03973970 -
Assessing the Ability of the T-SPOT®.TB Test (IQ)
|
||
Recruiting |
NCT04230395 -
Alcohol Reduction Among People With TB and HIV in India
|
N/A | |
Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
Active, not recruiting |
NCT02906007 -
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05917210 -
Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
|
N/A | |
Not yet recruiting |
NCT05845112 -
Start Taking Action For TB Diagnosis
|
||
Not yet recruiting |
NCT06017843 -
Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding
|
N/A | |
Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
Completed |
NCT02781909 -
Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis
|
Phase 2 |