In vivo study to monitor the sensitivity of Plasmodium falciparum and other species to Pyronaridineartesunate and Artemether-lumefantrine in Niger.
- Conditions
- Malaria
- Registration Number
- PACTR202105706263530
- Lead Sponsor
- European and Developping Countries Clinical Trials partnership EDCTP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 240
• 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
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;
Intercurrent pathology which may interfere with the classification of the therapeutic response;
Detection of an infection by another plasmodial species during monitoring;
Incorrect inclusion (non-compliance with inclusion criteria / non-inclusion)
Patient lost to follow-up
Appearance of a serious adverse event
Death or event endangering the participant's survival
Event resulting in a significant or lasting incapacity or handicap ...
Inability to take treatment
Repeated vomiting (= two)
Absence = 1 follow-up visit during periods taken with AL or Pyr-AS
Serious adverse event.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the sensitivity of Plasmodium falciparum to Pyronaridine-artesunate and Artemether-lumefantrine in Niger
- Secondary Outcome Measures
Name Time Method • Determine the clinical and parasitological response on D28 after molecular correction by PCR after treatment with Pyr-AS and LA;<br>• To assess the clinical tolerance of Pyr-AS and AL;<br>• Determine the parasite clearance time after treatment with Pyr-AS and AL;<br>• Determine the rate of reinfection within 28 days after treatment with Pyr-AS and AL.<br>