PACTR202308652843585
Not yet recruiting
未知
Clinical Diagnostic Performance Evaluation of an Anti-Measles IgM Lateral Flow Immunochromatographic Assay for Outbreak Detection and Surveillance in Senegal
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Measles
- Sponsor
- Institut Pasteur de Dakar
- Enrollment
- 850
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients (all ages) presenting to participating health centres:
- •\- 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
- •\- Clinical signs or symptoms that may be exacerbated by blood draw or upper respiratory sampling (e.g. stridor or severe respiratory distress)
- •\- Prior recruitment to the study
Outcomes
Primary Outcomes
Not specified
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