Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT05860920
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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05860920
Study Brief:
Protocol Section:
NCT05860920