Malaria
Conditions
Interventions
Artemether Lumefantrine
Sponsors
European and Developping Countries Clinical Trials partnership EDCTP
Eligibility
Sex/Gender
All
Inclusion 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
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; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the sensitivity of Plasmodium falciparum to Pyronaridine-artesunate and Artemether-lumefantrine in Niger | — |
Secondary
| Measure | Time frame |
|---|---|
| • Determine the clinical and parasitological response on D28 after molecular correction by PCR after treatment with Pyr-AS and LA; • To assess the clinical tolerance of Pyr-AS and AL; • Determine the parasite clearance time after treatment with Pyr-AS and AL; • Determine the rate of reinfection within 28 days after treatment with Pyr-AS and AL. | — |
Countries
Niger
Contacts
Public ContactSANOUSSI SAMUILA
Professeur
Outcome results
None listed