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.: PACTR202007553348930 Date of Approval: 10/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Parasite Clearance of Two Commonly Administered Artemisinin-Based Combination Therapies in Under-Five Children With Uncomplicated Malaria at Obafemi Awolowo University Teaching Hospital Complex, Ile-Ife.
Official scientific title Parasite Clearance of Two Commonly Administered Artemisinin-Based Combination Therapies in Under-Five Children With Uncomplicated Malaria at Obafemi Awolowo University Teaching Hospital Complex, Ile-Ife.
Brief summary describing the background and objectives of the trial it a a hospital based, open label, randomized controlled trial aimed at comparing the parasite clearance of two Artemisinin-Based Combination Therapies in Under-Five Children With Uncomplicated Malaria. These are Artemeter-Lumefantrine(AL) and Dihydroartemisinin-piperaquine phosphate ( DHPPQ). Sixty-one patients each will be randomised to the two treatment groups.
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: Drugs
Anticipated trial start date 01/09/2020
Actual trial start date
Anticipated date of last follow up 16/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 122
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 randomization table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group one dihydroartemisinin piperaquine phosphate DHAPQ Participants in this group will receive DHAPQ (P-Alaxin®, Bliss GVS Pharma Limited), given once daily, at the standard dose of 2.5 mg/kg of dihydroartemisinin and 20 mg/kg of piperaquine. Two formulations will be used (80mg dihydroartemisinin + 640mg piperaquine in 80ml suspension given at a dose of 2.4ml/kg and 40mg dihydroartemisinin + 320mg piperaquine tablet). All doses of DHAPQ would be given by directly observed therapy, supervised by the researcher and his two trained assistants who will be a physician and a nurse and patients observed for 30 minutes Three days. This would be administered once daily for the remaining three days. The doses of DHAPQ would also be administered by directly observed therapy, Thin and thick films for malaria parasite will be made from blood obtained from finger-prick and examined at screening on Day 0 to assess eligibility and parasite count respectively by a microbiology laboratory scientist and the researcher. Parasites will be counted using thick film and the parasite density (per µl of blood) will be calculated, assuming a normal leucocyte level of 8,000/µl . Thick film will also be made and examined on days 1,2,7,14,21 and 28. 61
Control Group Group one Artemeter Lumefantrine AL Participants randomized to group 1 would receive artemether-lumefantrine (AL) (Coartem® Dispersible, Novartis Pharmaceutical) which would be given as a co-formulated flavoured dispersible tablet of 20/120 mg. Participants weighing 5–14 kg will receive one tablet (20/120 mg), two tablets (40/240 mg) for bodyweight 15-24 kg and three tablets for those weighing 25 – 35 kg. Three days. This would be administered at 0h, 12h later, then twice daily for the remaining two days making a total of six doses. Thin and thick films for malaria parasite will be made from blood obtained from finger-prick and examined at screening on Day 0 to assess eligibility and parasite count respectively by a microbiology laboratory scientist and the researcher. Parasites will be counted using thick film and the parasite density (per µl of blood) will be calculated, assuming a normal leucocyte level of 8,000/µl Thick film will also be made and examined on days 1,2,7,14,21 and 28. The doses of AL at 0 h, 24 and 48 h would also be administered by directly observed therapy, while doses at 8h, 36h, and 60 h would be given by parents/guardians at home. 61 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(i) All patients between the age of 6 month and 59 months with signs and symptoms of acute uncomplicated malaria. (ii) Axillary temperature ≥37.5 ºC or history of fever during the past 24 hr. (iii) Ability to swallow oral medication. (iv) Microscopically confirmed asexual forms of P. falciparum with parasite density count of between 2000 and 200 000 parasites ⁄ µl. (v) Willingness of the parent/guardian to comply with protocol as regards the study visit schedule. (i) Those having symptoms and signs of severe falciparum malaria. (ii) A febrile condition due to diseases other than malaria e.g. measles, acute lower respiratory tract infection. (iii) Patients having severe malnutrition. (iv) Patients with sickle cell anaemia. (v) History of use of medication such as erythromycin, azithromycin, clindamycin and Septrin that might interfere with antimalarial pharmacokinetics. (vi) History of hypersensitivity to any of the study drugs will be excluded from the study. Preschool Child: 2 Year-5 Year 6 Month(s) 59 Month(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 14/10/2019 Ethics and Research Committe
Ethics Committee Address
Street address City Postal code Country
Obafemi Awolowo University Hospitals Complex Ile Ife 0220 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Therapeutic outcomes will be classified according to WHO guidelines as follows: Early treatment failure (ETF), late clinical failure (LCF), late parasitological failure (LPF), and adequate clinical and parasitological response (ACPR).6,7 ETF is defined as development of danger signs or severe malaria on days 1, 2 or 3 in the presence of parasitaemia, or parasitaemia on day 2 higher than day 0 count irrespective of axillary temperature, or parasitaemia on day 3 with axillary temperature 37ºc, or parasitaemia on day 3> 25% of day 0 count irrespective of axillary temperature. LCF is the development of danger signs or severe malaria and/or axillary temperature 37.5ºC, on any day from day 4 to 14, in the presence of parasitaemia without previously meeting any of the criteria of ETF. LPF is said to occur when there is parasitaemia on day 14 and axillary temperature < 37.5ºC without previously meeting any of the criteria of ETF or LCF. Adequate Clinical and Parasitological Response ACPR is the absence of parasitaemia on day 14 irrespective of axillary temperature without previously meeting any of the criteria of ETF, LCF, LPF. ACPR will be the primary endpoint while Day 3, 7, 14, 21 and 28
Secondary Outcome the comparison of fever clearance, parasite clearance and side effects of the three treatments will be the secondary endpoints. The Parasite Clearance Time is the time in hours from the first antimalarial dose till the first two consecutive thick blood films that are negative for asexual P. falciparum parasites after checking 200 oil immersion fields. Fever clearance time is the time in hours from the first antimalarial dose till the temperature first decreased to <37.5°C and remained below 37.5°C for 24 hours. Days 1, 2 and 3
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Urban Comprehensive Health Centre Town Planning Road Ile Ife 0220 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Personal General Out-patient Department Ile Ife 0220 Nigeria
Residency Training fund Obafemi Awolowo University Teaching Hospital Complex Ile Ife 0220 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Abdulakeem Department of Family medicine, Obafemi Awolowo University Teaching Hospital Complex Ile Ife 0220 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdulakeem Ahmed ahmediganna@gmail.com +2347039879808 General Out-Patient Department
City Postal code Country Position/Affiliation
IleIfe 0220 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Ibrahim Bello bello.ibrahim@gmail.com +2347019996169 Department of Family Medicine
City Postal code Country Position/Affiliation
Ile Ife 0220 Nigeria Chief Hospital Consultant
Role Name Email Phone Street address
Scientific Enquiries Temitayo Adewole tayoipinlaye@yahoo.com +2348033965675 Department of Family Medicine, Obafemi Awolowo University Teaching Hospitals Complex
City Postal code Country Position/Affiliation
Ile ife 0220 Nigeria Senior Hospital Consultant
Role Name Email Phone Street address
Public Enquiries Samuel Olowookere sanuolowookere@yahoo.com +2348135051248 Obafemi Awolowo University
City Postal code Country Position/Affiliation
Ile Ife 0220 Nigeria Senior Lecturer and Consultant Family Physician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We intend to share the Individual Participant Data set gotten from this study with the Nigeria Malaria Control Programme, and the World Health Organisation. This is to enhance policy making on the guideline of treatment of malaria Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol September 2020-Dec 2022 The access to the data set will be controlled by the principal investigator and the co-investigators, who will serve as the gatekeepers to the IPD. Access will be granted following an ethical approval
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not available for now No
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