Clinical Diagnostic Performance Evaluation of a Measles Rapid Test in Senegal

Launched by INSTITUT PASTEUR DE DAKAR · May 12, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new quick test for measles in health centers across Senegal. The goal is to see how accurate this rapid test is when used by health professionals who are not laboratory specialists. The test can be done using either a small drop of blood from a finger or a sample taken from the gums with a swab. Researchers will compare the results of this rapid test with the standard laboratory tests to see how well it works in real-life situations.

To participate in the study, patients must show symptoms of measles, such as a fever and a specific type of rash, and they should be within 28 days of the rash appearing. If they are under 18, a parent or guardian must provide consent, while those over 18 can give their own consent. Participants will have the opportunity to help improve measles testing in their community, and the study will also evaluate how easy the test is to use and how to best track the results.

Gender

ALL

Eligibility criteria

• 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 would be exacerbated with oral fluid sampling
• • They are significantly dehydrated and the mouth is very dry
• • They refuse or are not able to cooperate with oral fluid sampling