Tuberculosis Clinical Trial
— SOAROfficial title:
Nurse-Led, Symptom-Based Screening of Household Child Contacts of Tuberculosis Index Cases
Verified date | March 2020 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess implementation of a nurse-led, symptom-based screening program in local, decentralized clinics for tuberculosis (TB) screening of child contacts less than 5 years old who were exposed to tuberculosis in the home. This will allow nurses in decentralized clinics to either start IPT for those asymptomatic patients and refer symptomatic patients for evaluation of TB disease and possible antituberculous therapy (ATT).
Status | Completed |
Enrollment | 4054 |
Est. completion date | September 15, 2018 |
Est. primary completion date | September 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 5 Years |
Eligibility |
Inclusion Criteria: - Child less than five years old - Household contact of a drug-sensitive pulmonary or extrapulmonary TB index case (drug sensitivity is define as culture-confirmed OR absence of rifampin resistance on gene Xpert) admitted to one of the public clinics in the Matlosana sub-district on or after October 1, 2015. Exclusion Criteria: - Household contact of a drug-resistant TB index case. (Drug resistance defined either by culture or by presence of rifampin resistance on gene Xpert). |
Country | Name | City | State |
---|---|---|---|
South Africa | PHRU | Klerksdorp | Matlosana |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | United States Agency for International Development (USAID) |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of child contacts placed on IPT | The primary outcome is the mean percentage of identified contacts initiated on IPT or ATT | 2 years |
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