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New treatment option for Tuberculosis
Official title Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)
ClinicalTrials.gov ID: NCT05989802
What this study is testing
- What it's testing
- Every year there are an estimated 230,000 childhood deaths from TB. There is an urgent need for novel tests for TB diagnosis in children under 15 years.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 65. Healthy volunteers may be eligible.
You may be able to join if
- Participant eligibility criteria: Participants will include children (age \<15 years) who present to care with: A. 2 or more of the following:
- Unexplained cough for any duration
- TB contact or tuberculin skin test or interferon gamma release assay positive
- Abnormal chest X-ray (any abnormality) OR B. Any one of criteria A AND any one of the following:
- Unexplained weight loss OR unexplained failure to thrive OR Severe Acute Malnutrition
See the full eligibility criteria
- Participant eligibility criteria: Participants will include children (age \<15 years) who present to care with: A. 2 or more of the following:
- Unexplained cough for any duration
- TB contact or tuberculin skin test or interferon gamma release assay positive
- Abnormal chest X-ray (any abnormality) OR B. Any one of criteria A AND any one of the following:
- Unexplained weight loss OR unexplained failure to thrive OR Severe Acute Malnutrition
- Unexplained fever ≥2 weeks
- Unexplained lethargy or reduced playfulness ≥2 weeks The study will exclude participants who:
- Completed preventive or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);
- Have taken any medication with anti-mycobacterial activity for any reason for greater than 3 days at the time of enrollment (to reduce false-negatives);
- Are unable to return for follow-up visits; or
- Whose parents/guardians are unwilling to provide informed consent or who are unwilling to provide assent if applicable (age determined by local IRB) Assessment of the usability of novel TB tests: The study will also...
The study team makes the final eligibility decision.
Where it's taking place
- Maputo, Mozambique
- Cape Town, South Africa
- Kampala, Uganda
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Maputo, Mozambique; Cape Town, South Africa; Kampala, Uganda. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.