Clinical Diagnostic Performance Evaluation of a Measles Rapid Test in Senegal (NCT05860920) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Diagnostic Performance Evaluation of a Measles Rapid Test in Senegal
850 participantsStarted 2025-07
Plain-language summary
The goal of this study is to measure the accuracy of a new measles rapid test when used in clinical health centres in several regions of Senegal. The rapid test will be used to test patients for measles who attend the participating health centres with signs and symptoms suggestive of measles infection. The rapid test can be used with a drop of blood from a finger, or oral fluid sampled with a swab rubbed over the gums. The rapid test will be compared to the standard methods of diagnosis in the laboratory using blood samples and oral or throat samples taken for surveillance purposes.
The main questions the study aims to answer are:
1. What is the accuracy of the rapid test when used with capillary blood (a drop of blood from the finger tip) in health centres by non-laboratory health professionals?
2. What is the accuracy of the rapid test when used with oral fluid by non-laboratory health professionals?
In addition to measuring the accuracy of the test, data will also be collected on whether the test is easy and practical to use and how best to record the results.
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients presenting at study sites:
* For whom confirmatory diagnostic testing is currently indicated as per the national surveillance protocol
* With clinical signs and symptoms consistent with the WHO suspected measles case definition including: History of fever, or observed fever (\>37.5C) at presentation and a (non-vesicular) maculopapular rash; or clinically suspected measles
* ≤ 28 days after the onset of a rash
* Who if \<18 years of age, have written, informed consent from their legal guardian (and verbally assent if more than 7 years old)
* Who if more than 18 years, give written, informed consent
Exclusion Criteria:
* Withdrawal of consent or assent as described above, at any time.
* Unsuccessful venous blood sampling after a maximum of 3 attempts, or a serum sample is no longer available for any reason.
* Clinical signs or symptoms requiring immediate referral/transfer of the patient to another site or centre, and/or for whom participation would involve a delay of urgent clinical interventions or investigations (i.e. potential inclusion of patients requiring immediate clinical management should be deferred until the patient is clinically stable).
* Clinical signs or symptoms that may be exacerbated by blood draw or upper respiratory sampling (e.g. stridor or severe respiratory distress)
Participants who meet the inclusion criteria should be included in the study but without oral fluid sampling if:
* They have a sore mouth or gums that woul…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The clinical diagnostic performance of the RDT for measles case-confirmation using capillary blood by non-laboratory professional personnel under field conditions