Comparative Efficacy, Safety And Tolerability Of Three Treatment Regiments For Uncomplicated Falciparum Malaria

Comparative Efficacy, Safety And Tolerability Of Three Treatment Regiments For Uncomplicated Falciparum Malaria: Artesunate (3 Days) + Amodiaquine (3 Days) Vs. Artésunate (3 Days) + Sulfadoxine-Pyriméthamine (1day) Vs. Artésunate (5 Days)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201802003020160

Enrollment

750

Registered

2018-01-26

Start date

2002-12-22

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

Experimental comparison of combination therapies (2 arms) versus Monotherapy

Experimental comparison of combination therapies versus Monotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The following criteria needed to be met for intry into the study: - Adults or children aged 6 months or older and weighing more than 5Kg - Residents of Bougoula-Hameau during the entire follow up period - Oral treatment possible - Axiliary temperature >= 37.5oC . - Infection with Plasmodium specie with parasite density between 2000 and 200000 trophozoites/mm3. - Informed consent or informed assent obtained from the patient or parent/guardian

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA - Presence of symptoms of severe or cerebral malaria: coma, unconsciousness, recent or repeated seizures, acute pulmonary edema, unable to drink, repeated vomiting, macroscopic hemoglobinueria, jaundice, hemorrhagic shock (systolic blood pressure 3mg/dL). - Concomitant severe illness, - Severe anemia: hemoglobine <= 5g/dL - Allergy to one of the study drugs - Pregnancy (disclosed or clinically patent pregnancy). - Documented consumption of one of the study drugs during the preceding 7 days.

Design outcomes

Primary

Measure	Time frame
Evaluation of Treatment Efficacy;Tolerance and safety:	—

Secondary

Measure	Time frame
Efficacy, tolerance and safety	—

Countries

Mali

Contacts

Public ContactMamadou Marouf KEITA

Professor/President of Ethics Committee (FMPOS)

mdiakite@icermali.org(00223) 66722022/ 73055084

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026