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.: PACTR202002644579177 Date of Approval: 20/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Dihydroartemisinin–Piperaquine versus Sulfadoxine–Pyrimethamine Use for the Prevention of Malaria during Pregnancy
Official scientific title Superiority Trial of Intermittent Treatment with Dihydroartemisinin–Piperaquine versus Sulfadoxine–Pyrimethamine for the Prevention of Malaria during Pregnancy
Brief summary describing the background and objectives of the trial Malaria in pregnancy is a leading cause of adverse maternal and fetal outcomes in sub-Saharan Africa. In an effort to address this problem, the World Health Organization recommended intermittent preventive treatment during pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) as one of the measures to control malaria in most endemic countries. However, the implementation of this measure is being confronted by rising levels of parasite resistance to SP in sub-Saharan Africa. This proposed study seeks to evaluate a possible superior alternative drug for IPTp with a view to reducing the adverse outcomes of malaria to mother and neonate.
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 Prevention
Anticipated trial start date 02/03/2020
Actual trial start date 01/07/2020
Anticipated date of last follow up 31/05/2021
Actual Last follow-up date 30/06/2021
Anticipated target sample size (number of participants) 250
Actual target sample size (number of participants) 206
Recruitment status Closed to recruitment,follow-up continuing
Publication URL https://rdcu.be/c4Bw8
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dihydroartemisinin and Piperaquine 40 mg of Dihydroartemisinin and 320 mg of Piperaquine of 3 tablets single dose daily for 3 consecutive days At 20, 28, and 36 weeks of pregnancy, respectively. Ibasunate® by Elbe Pharma 125
Control Group Sulfadoxine and Pyrimethamine 500 mg of sulfadoxine and 25 mg of pyrimethamine of 3 tablets taken together on the first day and 3 tablets of placebo also taken together for additional 2 days. At 20, 28, and 36 weeks of pregnancy Amalar® by Elbe Pharma 125 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Pregnant women aged 15-49 years • Attending antenatal clinic (ANC) for the first time in this current pregnancy • Gestation of 16-20 weeks (as assessed by LMP and/or ultra-scan) • HIV-negative pregnant women • No current history of receiving IPTp-SP • Willing to provide informed written consent • Planning to stay in Maiduguri and attending ANC and have child delivery at University of Maiduguri Teaching Hospital, Maiduguri • A history of allergic reaction to sulfa drugs (SP or cotrimoxazole) or DP • Having haemoglobin level < 7 g/dl • Positive test for falciparum malaria • History of receipt of antimalarials or antibiotics with antimalarial activity (cotrimoxazole, rifampin, doxycycline, clindamycin, tetracycline, erythromycin, azithromycin, chloramphenicol) in the past month • Women with sickle cell disease • Women with high-risk pregnancies (presence of high blood pressure and diabetes) • HIV- Positive women Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 49 Year(s) Female
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 24/12/2019 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Bama Road, Maiduguri Maiduguri 600230 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome peripheral and/or placental parasitaemia Delivery
Secondary Outcome 1. Preterm delivery at birth (defined as birth at < 37 weeks’ gestation evaluated by early ultrasound scan or calculated gestational age by date). 2. Low birth weight (<2500 g). 3. Spontaneous abortion (defined as the expulsion of a foetus before 28 weeks’ gestation). 4. Stillbirth (defined as the delivery of a dead child after 28 weeks’ gestation). 5. Gross congenital anomaly. 6. Maternal anaemia (Hb <11 g/dl) at delivery. 7. Adverse effects of SP (skin rash, anorexia, diarrhoea, dizziness, headache, itch, fatigue, nausea/vomiting, fever, swollen tongue, arrhythmia, and any other ones linked to the drug) and DP (Anorexia, dysphagia, diarrhoea, dizziness/vertigo, headache, itch, asthenia, nausea/vomiting, fever, generalized irregular twitching movement- choreoathetois, and any other one linked to the drug). 24 weeks of gestation - delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Maiduguri Teaching Hospital Bama Road Maiduguri Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Royal Society of Tropical Medicine and Hygiene Northumberland House 303-306 High Holborn WC1V 7JZ London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Royal Society of Tropical Medicine and Hygiene Northumberland House 303-306 High Holborn London United Kingdom Charities/Societies/Foundation
Secondary Sponsor National Institute for Health Research Whitehall London United Kingdom Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Prof. Ado Danazumi Geidam Department of Obstetrics and Gynaecology, University of Maiduguri Teaching Hospital Maiduguri Nigeria
Dr. Audu Abdullahi Bukar Department of Haematology, University of Maiduguri Teaching Hospital Maiduguri Nigeria
Dr. Abba Zarami Bukar Department of Histopathology, University of Maiduguri Teaching Hospital Maiduguri Nigeria
Dr. John David Ohieku Department of Clinical Pharmacy and Pharmacy Administration, University of Maiduguri Maiduguri Nigeria
Alhaji Bukar Musa Department of Medical Laboratory, University of Maiduguri Maiduguri Nigeria
Prof. Timothy Samuel Yerima Department of Pharmacology and Toxicology, University of Maiduguri Maiduguri Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Roland Nnaemeka Okoro rolandokoro@unimaid.edu.ng +2348032576716 Department of Clinical Pharmacy and Pharmacy Administration
City Postal code Country Position/Affiliation
Maiduguri Nigeria Lecturer I University of Maiduguri
Role Name Email Phone Street address
Public Enquiries John David Ohieku ohijodav@unimaid.edu.ng +2348036040798 Department of Clinical Pharmacy and Pharmacy Administration
City Postal code Country Position/Affiliation
Maiduguri Nigeria Associate Professor University of Maiduguri
Role Name Email Phone Street address
Scientific Enquiries Ado Danazumi Geidam adogeidam@yahoo.com +2348032806072 Department of Obstetrics and Gynaecology, University of Maiduguri Teaching Hospital
City Postal code Country Position/Affiliation
Maiduguri Nigeria Professor University of Maiduguri
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 year IPD will be made available to researchers by the principal investigator on request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 24/12/2020 Progress 01 Jul 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 25/12/2021 Error was detected 01 Jul 2021 01 Jul 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 24/12/2020 Progress 31 Dec 2020 31 May 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 24/12/2020 Progress 30 Jun 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 25/12/2021 Updated record 206
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 22/06/2020 We have started recruitment Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 24/12/2020 Progress Recruiting Closed to recruitment,follow-up continuing
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Publication URL 02/02/2023 Findings are now published https://rdcu.be/c4Bw8
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 25/12/2021 Omission detected • Pregnant women aged 15-49 years • Attending antenatal clinic (ANC) for the first time in this current pregnancy • Gestation of 20 weeks (as assessed by LMP) • HIV-negative pregnant women • No current history of receiving IPTp-SP • Willing to provide informed written consent • Planning to stay in Maiduguri and attending ANC and have child delivery at University of Maiduguri Teaching Hospital, Maiduguri • Pregnant women aged 15-49 years • Attending antenatal clinic (ANC) for the first time in this current pregnancy • Gestation of 16-20 weeks (as assessed by LMP and/or ultra-scan) • HIV-negative pregnant women • No current history of receiving IPTp-SP • Willing to provide informed written consent • Planning to stay in Maiduguri and attending ANC and have child delivery at University of Maiduguri Teaching Hospital, Maiduguri
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 19/02/2020 As requested by the reviewer Undecided Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 19/02/2020 As requested by the reviewer Summary results
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 19/02/2020 As requested by the reviewer 1 year
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 19/02/2020 As requested by the reviewer IPD will be made available to researchers by the principal investigator on request
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 19/02/2020 As requested by the reviewer Study Protocol, Statistical Analysis Plan, Informed Consent Form