Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201802003020160 Date of Approval: 26/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Efficacy, Safety And Tolerability Of Three Treatment Regiments For Uncomplicated Falciparum Malaria
Official scientific title 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)
Brief summary describing the background and objectives of the trial The spread of malaria parasites resistant to safe and affordable drugs is greatly hampering the control of malaria in Africa. As a consequence, nearly all sub-Saharan African countries have either changed their antimalarial treatment guidelines. The WHO now recommends the use of combination therapies rather than monotherapies for the treatment of uncomplicated malaria. The combination therapies have been shown to deter the spread of antimalarial drug resistance and to decrease malaria transmission in South-Est Asia. In Mali, we have documented a steady increase in the prevalence of P. falciparum resistance to chloroquine. A clear choice of artemisinin-based combination therapy (ACT) as new policy was made and studies were initiated to identify the best ACT for Mali. Although the results of these studies were pending, following recommendations from the WHO, the National Malaria Control Program (NMCP) of Mali has selected artemether-lumefantrine as the first line therapy for uncomplicated malaria for sites where microscopic diagnosis of malaria is available. Several studies aimed at evaluating the efficacy and safety of artemisinine based combination therapies have been conducted. Most of these studies compare artesunate (AS) plus sulfadoxine-pyriméthamine (SP) or amodiaquine (AQ) versus monotherapies with SP or AQ. These studies show the superiority of the combination over the monotherapies. However, at the beginning of this study no study comparing AS/AQ vs. AS/SP in the same epidemiological condition was available. Similarly, no study comparing these combinations to AS monotherapy was available. The overall aim of this study is to promote evidence-based antimalarial treatment adjustments in Mali. General Objective Test the hypothesis that three-day artesunate combined with AQ and SP are at least as efficacious as five-day AS alone.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 22/12/2002
Actual trial start date 22/12/2002
Anticipated date of last follow up 21/12/2004
Actual Last follow-up date 14/10/2004
Anticipated target sample size (number of participants) 750
Actual target sample size (number of participants) 752
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
IM BKO 0202 IRB FMPOS
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Patients were randomly assigned to treatment arms according to a computer generated randomization list using blocks of 6 by Sanofi-Synthelabo Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Experimental comparison of combination therapies (2 arms) versus Monotherapy Doses were weight and arm dependent: twice a days for combinations groups vs 1 dose per day for monotherapy group 3 days for combination versus 5 days for Monotherapy Randomized control trial 250 Active-Treatment of Control Group
Experimental Group Experimental comparison of combination therapies versus Monotherapy Doses were weight and arm dependent: twice a day 3 days randomized control trial 250
Control Group Experimental comparison of combination therapies versus Monotherapy Doses were weight dependent: once a day 5 days Randomized control trial 250 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 - 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 < 70 mm Hg in adults, <50 in children), spontaneous bleeding, hypoglycemia (<40mg/dl), renal failure (creatinine > 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. 6 Month(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/06/2002 FMPOS
Ethics Committee Address
Street address City Postal code Country
Point G Bamako Bamako 1805 Mali
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Evaluation of Treatment Efficacy -Adequate clinical and parasitological response (ACPR) by day 14. - early treatment failure (ETF) - late clinical failure (LCF), - late parasitological failure (LPF) - adequate clinical and parasitological response (ACPR)
Primary Outcome Tolerance and safety: - incidence of clinical adverse events - modification of biological parameters
Secondary Outcome Efficacy, tolerance and safety - Parasite clearance time - fever clearance time - rate of gametocyte carriage and gametocyte density on days 7 and 14 - evolution of anemia - clinical and parasitoogical cure at day 28
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bougoula-Hameau, Sikasso Centre de Santé de Bougoula-Hameau, Sikasso Sikasso 1805 Mali
FUNDING SOURCES
Name of source Street address City Postal code Country
IMPACT MALARIA/ SANOFI-SYNTHELABO Paris Paris France
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor SANOFI-SYNTHELABO Paris France Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Malaria Research and Training Center (MRTC)/ University of Bamako, Mali Point G/ FMOS-FAPH Bamako 1805 Mali
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdoulaye DJIMDE adjimde@icermali.org +223 66744280 Point G- Bamako
City Postal code Country Position/Affiliation
Bamako 1805 Mali Teaching Professor at Faculty of Pharmacy of Bamako, Mali
Role Name Email Phone Street address
Public Enquiries Mamadou Marouf KEITA mdiakite@icermali.org (00223) 66722022/ 73055084 Point G Bamako
City Postal code Country Position/Affiliation
Bamako BP 805 Mali Professor/President of Ethics Committee (FMPOS)
Role Name Email Phone Street address
Scientific Enquiries Ogobara DOUMBO okd@icermali.org (00223) 66753396 Point G Bamako
City Postal code Country Position/Affiliation
Bamako BP 1805 Mali Professor and Director of Malaria Research and Training Center (MRTC)
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information