PACTR202105706263530
Not yet recruiting
Phase 4
In vivo study to monitor the sensitivity of Plasmodium falciparum and other species to Pyronaridineartesunate and Artemether-lumefantrine in Niger.
European and Developping Countries Clinical Trials partnership EDCTP0 sites240 target enrollmentJuly 3, 2020
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- European and Developping Countries Clinical Trials partnership EDCTP
- Enrollment
- 240
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged 6 months and over with P. falciparum and / or other species;
- •Have an axillary temperature greater than or equal to 37\.5 ° C or failing this, the onset of a fever in the last 24 hours must be found during questioning.
- •Parasitaemia must be between 1000 and 200,000 / µL;
- •Informed consent / assent must be obtained from the patient or, if it is a child, from the person responsible for it after receiving specific information from the protocol
Exclusion Criteria
- •Non\-inclusion criteria
- •The presence of one or more general danger signs or any sign of severe or complicated malaria defined by WHO
- •Refusal to sign or affix his fingerprint on the informed consent;
- •Any contraindication to any of the molecules in a combination or the presence of a history of allergy;
- •Pregnancy clinically evident or found on interrogation;
- •Patients who have received antimalarial treatment for less than 14 days.
- •Study discontinuation criteria for participants
- •Withdrawal of informed consent;
- •Protocol violation:
- •Administration of an antimalarial treatment other than Pyr\-AS or AL;
Outcomes
Primary Outcomes
Not specified
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