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.: PACTR201508001188143 Date registered: 03/07/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Open randomized study for the evaluation of activities of AS/AQ (co-packaged and co-formulated) versus AL on asexual & sexual paraistes in children
Official scientific title An open label, randomized trial of the therapeutic efficacy, safety and tolerance of co-packaged amodiaquin plus artesunate versus co-formulated artesunate plus amodiaquine versus artemether lumefatrine for the treatment of uncomplicated Plasmodium falciparum malaria in children
Brief summary describing the background and objectives of the trial Falciparum malaria has remained a major cause of morbidity and mortality in African Children. Of the modalities available for reduction of childhood morbidity and mortality due to falciparum malaria in tropical Africa, chemotherapy appears to be the most promising. However, the spraed of parasite resistant to chloroquine and pyrimethamine-sulfadixine has created urgent needs for the evaluation of effective alternative drugs or drug combination for the treatment of acute falciparum malaria. The primary study objectives are: T evaluate the day 28-42 polymerase chain reaction (PCR)-corrected cure rates in children with acute, symptomatic, uncomplicated Plasmodium falciparum malariatreated with co-packaged amodiaquine plus artesunate, co-formulated artesunate plus amodiaquine or artemether-lumefantrine The secondary objectives are: To compare the proportion of parasitaemia or fever on days 3, 7 and 14 To compare the prevalence and intensities of gametocytaemia on days 7, 14 and 28. To evaluate the changes in haaemoglobin or haematocrit between day 0 or packed cell volume between day0 and 28
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Other
Anticipated trial start date 01/08/2009
Actual trial start date
Anticipated date of last follow up 31/05/2009
Actual Last follow-up date 31/05/2009
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 291
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 amodiaquine plus artesunate 10mg/body weight amodiaquine plus 4mg/body weight of artesunate (once daily) 3 days 105
Experimental Group artemisinin plus amodiaquine (co-formulated) 4mg/body weight of artesunate plus10mg/body weight of amodiaquine(once daily) 3 days 105
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 81
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
boby weight at least 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) 15 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 07/03/2006 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 28-42 days PCR-corrected cure rates 28 35 42
Secondary Outcome Proportion of patients with parasitaemia or fever 3 7 14
Secondary Outcome Prevalence and intesities of gametocytaemia 7 14 28
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Malaria Research Clinic and Laboratories Institute of Medical Research and Training, College of Medicine, University of Ibadan Ibadan 23402 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Swiss Pharma Nigeria Limited 5, Dopemu Road Agege, Lagos State 23401 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Swiss Pharma Nigeria Limited 5, Dopemu Road Agege, Lagos State 23401 Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Malaria Research Clinic Institute of Medical Research and Training, College of Medicine, University of Ibadan Ibadan 23402 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Akintunde Sowunmi akinsowunmi@hotmail.com 08052157893 Dept. Clinical Pharmacology, University College Hospital
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. Clinical Pharmacology, University College Hospital
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. Clinical Pharmacology, University College Hospital
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 Public title 29/07/2015 New information Open randomized study for the evaluation of activities of AS/AQ (co-packaged and co-formulated) versus AL on asexual & sexual paraistes in children Open randomized study for the evaluation of activities of AS/AQ (co-packaged and co-formulated) versus AL on asexual & sexual paraistes in children
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 29/07/2015 New information Falciparum malaria has remained a major cause of morbidity and mortality in African Children. Of the modalities available for reduction of childhood morbidity and mortality due to falciparum malaria in tropical Africa, chemotherapy appears to be the most promising. However, the spraed of parasite resistant to chloroquine and pyrimethamine-sulfadixine has created urgent needs for the evaluation of effective alternative drugs or drug combination for the treatment of acute falciparum malaria. The primary study objectives are: T evaluate the day 28-42 polymerase chain reaction (PCR)-corrected cure rates in children with acute, symptomatic, uncomplicated Plasmodium falciparum malariatreated with co-packaged amodiaquine plus artesunate, co-formulated artesunate plus amodiaquine or artemether-lumefantrine The secondary objectives are: To compare the proportion of parasitaemia or fever on days 3, 7 and 14 To compare the prevalence and intensities of gametocytaemia on days 7, 14 and 28. To evaluate the changes in haaemoglobin or haematocrit between day 0 or packed cell volume between day0 and 28 Falciparum malaria has remained a major cause of morbidity and mortality in African Children. Of the modalities available for reduction of childhood morbidity and mortality due to falciparum malaria in tropical Africa, chemotherapy appears to be the most promising. However, the spraed of parasite resistant to chloroquine and pyrimethamine-sulfadixine has created urgent needs for the evaluation of effective alternative drugs or drug combination for the treatment of acute falciparum malaria. The primary study objectives are: T evaluate the day 28-42 polymerase chain reaction (PCR)-corrected cure rates in children with acute, symptomatic, uncomplicated Plasmodium falciparum malariatreated with co-packaged amodiaquine plus artesunate, co-formulated artesunate plus amodiaquine or artemether-lumefantrine The secondary objectives are: To compare the proportion of parasitaemia or fever on days 3, 7 and 14 To compare the prevalence and intensities of gametocytaemia on days 7, 14 and 28. To evaluate the changes in haaemoglobin or haematocrit between day 0 or packed cell volume between day0 and 28
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 29/07/2015 New information An open label, randomized trial of the therapeutic efficacy, safety and tolerance of co-packaged amodiaquin plus artesunate versus co-formulated artesunate plus amodiaquine versus artemether lumefatrine for the treatment of uncomplicated Plasmodium falciparum malaria in children An open label, randomized trial of the therapeutic efficacy, safety and tolerance of co-packaged amodiaquin plus artesunate versus co-formulated artesunate plus amodiaquine versus artemether lumefatrine for the treatment of uncomplicated Plasmodium falciparum malaria in children
Section Name Field Name Date Reason Old Value Updated Value
29/07/2015 New information Principal Investigator Public Enquiries
Section Name Field Name Date Reason Old Value Updated Value
Intervention InterventionTypeID 29/07/2015 New information Experimental group Experimental group
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 PACTR UPDATE 01 Jan 0001 31 May 2009
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 09/07/2018 PACTR UPDATE Paediatrics