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.: PACTR201508001193368 Date registered: 08/07/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative study of the effect and tolerance of sulfalene/pyrimethamine/amodiaquine versus artemether/lumefantrine for treatment of malaria
Official scientific title Comparative study of the efficiency and tolerance of the sulfalene/pyrimethamine/amodiaquine versus artemether/lumefantrine for the treatment of simple Plasmodium falciparum malaria
Brief summary describing the background and objectives of the trial Malaria, as a rampant and severe disease, is a major public health concern in tropical countries. For many years, chloroquine has been the choice drug for the treatment of simple malaria. With the continued resistance of Plasmodium falciparum, malaria specialists believe that it is urgent to redefine first line therapeutic schedules and strategies by using more efficient combinations. Therefore, the combinations have to be assessed in the field among the populations most vulnerable and most exposed to malaria. Primary objective is to compare efficacy based on the number of people who were cured 42 days after the use of the sulfalene/pyriomethamine/amodiaquine versus artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria. Secondary objectives are: To compare the efficacy in clinical terms (thermal clearance) To compare parasite clearance To compare the tolerance and safety of the treatments To compare the rate of gametocyte clearance after treatment
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: Other
Anticipated trial start date 01/11/2005
Actual trial start date 01/11/2005
Anticipated date of last follow up 31/01/2006
Actual Last follow-up date 31/01/2006
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 181
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 Simple randomization using a randomisation table Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group artemether plus lumefantrine 5-14 kg (20/120mg of artemether/lumefantrine), 15-24 kg (40/240mg of artemether/lumefantrine), 25-34 kg (60/360mg of artemether/lumefantrine) & >34 kg (80/480mg of artemether/lumefantrine) 2ce daily 3 days 90
Experimental Group amodiaquine plus sulpahalene-pyrimethamine <12kg 100mg AQ (D 0-2) & 250 mg of SP (D0). 12-20kg: 200mg AQ & 500mg SP. 20 -30 kg: 300mg AQ & 750 SP. 31-52 kg 400mg AQ & 1000mg SP. >50mg: 600mg AQ & 1500 SPSPand 3 days 91
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
boby weight >/= 5 kg History of fever microscopically confirmed pure Plasmodium falciparum infection >/= 2000/uL Presence or history of fever (temp. >37.4) written informed consent severe malaria History of alergy to study drugs Presence of concomitant illness Signs of severe malnutrition Patient with history of hepatic, cardiac or renal disease. 6 Month(s) 10 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 25/10/2005 State Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Ministry of Health, Ibadan 23402 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical and parasitological cure day 1 day 2 day 3 day 7 day 14 day 21 day 28
Secondary Outcome Parasites and fever clearance times day 0 day 1 day 2 day 3 day 7 day 14 day 21 day 28
Secondary Outcome Gametocytaemia day 0 day 1 day 2 day 3 day 7 day 14 day 21 day 28
Secondary Outcome adverse drug events day 0 day 1 day 2 day 3 day 7 day 14 day 21 day 28
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Malaria Research Clinic and Laboratories Inst. of Medical Research and Training, College of Medicine Ibadan 23402 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Pfizer Global pharmaceuticals 11A, Osborne Road, Ikoyi, Lagos 23401 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pfizer Global pharmaceuticals 11A, Osborne Road, Ikoyi, Lagos 23401 Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Malaria Research Clinic and Laboratories Inst. of Medical Research and Training, College of Medicine Ibadan 23402 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Akintunde Sowunmi akinsowunmi@hotmail.com 08052157893 Dept. of Pharmacology & Therapuetics, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 23402 Nigeria Professor
Role Name Email Phone Street address
Public Enquiries Akintunde Sowunmi akinsowunmi@hotmail.com 08052157893 Dept. of Pharmacology & Therapuetics, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 23402 Nigeria Professor
Role Name Email Phone Street address
Scientific Enquiries Akintunde Sowunmi akinsowunmi@hotmail.com 08052157893 Dept. of Pharmacology & Therapuetics, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 23402 Nigeria Professor
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 URL Hyperlinks Baseline Characters Participant Flow Adverse Events Outcome Measures Description
Link To Protocol
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 11/08/2015 updated information 181
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 31/07/2015 New information Pfizer Glober pharmaceuticals Pfizer Global pharmaceuticals
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 09/07/2018 PACTR UPDATE Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 09/07/2018 PACT UPDATE 01 Jan 0001 31 Jan 2006