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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: www.pactr.org

Trial no.: PACTR201105000286876 Date registered: 2011/03/31
TRIAL DESCRIPTION
Public title EDCTP longitudinal study
Official scientific title A Phase IIIb/IV comparative, randomised, multi-centre, open label, parallel 3-arm clinical study to assess the safety and efficacy of repeated administration of
Brief summary describing the background
and objectives of the trial
there are limited data in term of safety and public health benefit in the use of the same ACT during repeated malaria episodes treatment particularly for PA and DHA-PQP. The objectives of this study are to compare the efficacy and the safety of repeated ACT therapy over a period of 2 years (pyronaridine-artesunate or dihydroartemisinin-piperaquine will be compared to either artesunate-amodiaquine or artemether-lumefantrine) in children and adults.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) WANECAM-EDCTP
Disease(s) or condition(s) being studied Malaria ,
Purpose of the trial Treatment
Anticipated trial start date 2011-06-01
Actual trial start date
Anticipated date of last follow up 2014-06-29
Actual date of last follow up
Anticipated target sample size (number of participants) 4032   
Actual target sample size (number of participants)   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID
IP_07_ 31060_002 EDCTP
SP-C-013-11 MMV

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
Parallel: different groups receive different interventions at same time during study Randomised Block-randomization will be done to allocate the patients to the three treatment arms for each site within the country using computer software program Sealed opaque envelopes Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Eurartesim®: dihydroartemisinin-piperaquine There are 2 strength tablets:- 20:160 mg and 40:320 mg Administered once daily for 3 days. Eurartesim¿ is a fixed-dose Artemisinin-based Combination Therapy (ACT) which contains dihydroartemisinin (a derivative of artemisinin) and piperaquine. The drug is made by Sigma-Tau S.p.A. It combines in a single tablet a short-lived but potent artemisinin-based active ingredient (dihydroartemisinin) with a second antimalarial (piperaquine) which remains longer in the body. 1344
Control group ASAQ-Winthrop/Coarsucam: amodiaquine-artesunate . There are 3 strength tablets 25:67.5 mg;50:135 mg;100:270 Administered once daily for 3 days. Winthrop® is artesunate and amodiaquine fixed dose combination, ASAQ. The drug is indicated in the treatment of uncomplicated Plasmodium falciparum malaria. It is manufactured by Sanofi-aventis 896 Active
Experimental group Pyramax: pyronaridine-artesunate Dose based on body weight:between 1 to a maximum of 4 sachets/tablets per day Administered once daily for 3 days Pyramax is a fixed-dose combination of pyronaridine and artesunate has completed development as a once daily, 3-day treatment for uncomplicated P. falciparum and blood stage P. vivax malaria in infants, children and adults. It is manufactured by Shin Poong Pharmaceuticals ,South Korea 1344
Control group Coartem-Dispersible and Coartem: artemether-lumefantrine Dose based on body weight:between 2 to a maximum of 4 tablets per day Administered twice daily for 3 days Coartem-Dispersible and Coartem is a fixed dose combination. The drug is indicated in the treatment of uncomplicated malaria. It is manufactured by Novartis 448 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
1. Male or female patients from 2 years of age (6 months and above after the DSMB review (first 40 Pyramax patients have been re-treated at least once). 2. Body weight greater than or equal to 15 kg (5 kg and above after the DSMB review and when Pyronaridine- artesunate granule become available) with no clinical evidence of severe malnutrition. 3. Presence of acute uncomplicated Plasmodium sp. malaria by: a. Fever, as defined by axillary temperature ¿ 37.5°C or oral/rectal/tympanic temperature ¿ 38°C, or history of fever in the previous 24 hours (not needed at reinclusion) and, b. Positive microscopy of Plasmodium sp. with parasite density less than 200,000 parasites/¿l 4. Written informed consent, in accordance with local practice, provided by patient and/or parent/guardian. If the patient is unable to write, witnessed consent is permitted according to local ethical considerations. 5. Ability to swallow oral medication. 6. No documented malaria treatment for at least 2 weeks since last treatment for malaria (4 weeks for re-inclusion) 7. Ability and willingness to participate based on information given to parent or guardian and access to health facility. The patient is to comply with all scheduled follow-up visits. 1. Signs and symptoms of severe/complicated malaria. 2. Severe vomiting, defined as more than three times in the 24 hours prior to inclusion in the study or inability to tolerate oral treatment, or severe diarrhoea defined as 3 or more watery stools per day. 3. Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, QTc interval greater than 450 milliseconds[Note that a QTc ¿ 450 msec with either Bazett or Fridericia correction will be acceptable]), respiratory (including active tuberculosis), history of jaundice, hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological, endocrine, infectious, malignancy, psychiatric, generalised anxiety, psychosis, schizophrenia or other major psychiatric disorders), history of convulsions or other abnormality (including recent head trauma). 4. Anaemia, as defined by Hb < 7 g/dL. 5. Febrile conditions caused by diseases other than malaria at the first inclusion and if oral treatment is not possible for the subsequent episode. 6. Hypersensitivity or allergic to study drug 7. Use of any other antimalarial agent, including traditional medicines known to have antimalarial properties, within 2 weeks prior to start of the study. 8. Female patients of child-bearing potential (>12 year old) must be neither pregnant (as demonstrated by a negative pregnancy test) nor planning to become pregnant nor lactating, during each 42 day period after treatment 9. Received an investigational drug within the past 4 weeks. 10. Known or suspected chronic alcohol abuse 11. Known active Hepatitis A, Hepatitis B or Hepatitis C. 12. Known positive for HIV antibody. 13. Liver function tests [ALT levels] more than 2 times upper limit of normal. 14. Known significant renal impairment as indicated by serum creatinine of more than 1.5 x ULN. 0 Year 100 Years 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 2010/12/21 Ethical Committee Faculté de Médecine de Pharmacie et d'Odonto-Stomatologie (FMPOS)
Ethics Committee Address
Street address City Postal code Country
BP 1805, Point G Bamako BP 1805 Mali
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 2011/01/05 Comite d'Ethique pour la Recherche en Sante
Ethics Committee Address
Street address City Postal code Country
Ministere de la Sante Ouagadougou Burkina Faso
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 2011/01/05 Comite d'Ethique pour la Recherche en Sante
Ethics Committee Address
Street address City Postal code Country
Ministere de la Sante Ouagadougou Burkina Faso
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 2011/01/11 Comite National d'Ethique pour la Recherche en Sante
Ethics Committee Address
Street address City Postal code Country
Conakry Guinea

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The incidence rate of malaria and repeated treatment safety over 2 years Once a patient is randomized to a study arm, she/he will be treated with the same study drug for the subsequent uncomplicated malaria episodes for up to 2 years after the first randomization. Hematology, Biochemistry and Clinacal safety will be assessed over the 2 years period of the study
Secondary Outcome Efficacy Efficacy of study drugs on Day 42 or Day 63 will according to WHO guidelines as well as molecular drug resistance be assessed over the 2 years period.

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
IRSS Avenue de la Liberté Bobo-Dioulasso 01 BP 545 Burkina Faso
MRTC, University of Bamako Point G BP 1805 Bamako BP 1805 Mali
CNFSR Maferenya Maferenya Conakry BP 2649 Guinea
CNRFP Ministere de la Sante Ouagadougou 01 BP 2208 Burkina Faso

FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP P.O. Box 93015, 2509 AA The Hague P.O. Box 93015 Netherlands
MMV Route de Pré-Bois Geneva PO Box 1826 Switzerland

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Bamako RECTORAT BADALABOUGOU Bamako BP E.2528 Mali University

COLLABORATORS
Name Street address City Postal code Country
MRTC, University of Bamako Point G Bamako BP 1805 Mali
CNRFP Ministere de la Sante Ouagadougou 01 BP 2208 Burkina Faso
IRSS Direction Régionale de l'Ouest Bobo-Dioulasso 01 BP 545 Burkina Faso
CNFSR,Maferenya CNFSR Maferenya Conakry BP 2649 Guinea
MRC Unit Malaria Research Center Banjul P.O. Box 273 Gambia
Karolinska University Hospital Karolinska University Hospital Stockholm SE-171 76 Sweden
Heidelberg University School of Medicine Department of Infectious Diseases Heidelberg 69120 Germany
LSHTM, UK. Faculty of Infectious & Tropical Diseases London WC1E 7HT United Kingdom
University Lyon 1 8 avenue Rockefeller Lyon 69373 Lyon cedex 08 France

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Abdoulaye Djimde adjimde@mrtcbko.org +223-20-22-81-09 +223-20-22-81-09
Street address City Postal code Country Position / Affiliation
Point G Bamako BP 1805 Mali Project Coordinator
Role Name Email Phone Fax
Public Enquiries Dr Sodiomon B. Sirima s.sirima.cnlp@fasonet.bf + 226 50 30 52 20 + 226 50 30 12 86
Street address City Postal code Country Position / Affiliation
Ministere de la Sante Ouagadougou 01 BP 2208 Burkina Faso Clinical trial project leader
Role Name Email Phone Fax
Public Enquiries Ms Aissata Diallo aissataamadou@mrtcbko.org (223) 76432744 (223) 20226832
Street address City Postal code Country Position / Affiliation
Point G Bamako 1805 Mali Administrative Coordinator
Role Name Email Phone Fax
Scientific Enquiries Dr Issaka Sagara isagara@mrtcbko.org (223) 76459079 (223) 20226832
Street address City Postal code Country Position / Affiliation
Point G Bamako 1805 Mali Research Associate