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.: PACTR201802003063273 Date of Approval: 07/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sulphadoxine/Pyrimethamine and Proguanil for malaria prophylaxis in Sickle Cell pregnancy: A Randomized Controlled Trial (SPICKLE TRIAL)
Official scientific title Sulphadoxine/Pyrimethamine and Proguanil for malaria prophylaxis in Sickle Cell pregnancy: A Randomized Controlled Trial (SPICKLE TRIAL)
Brief summary describing the background and objectives of the trial Background: Sulphadoxine/Pyrimethamine is currently drug of choice for malaria prophylaxis in pregnancy according to World Health organization (WHO) guideline. Its been found to be more effective than Pyrimethamine and Chloroquine which were used previously and later found to be associated with high rates of drug resistance. Despite this, Proguanil and Pyrimethamine appear to be commonest medication for malaria prophylaxis in individuals with sickle cell disease, including pregnant HbSS women in our environment. Currently, Proguanil is used daily and is more expensive than the monthly-dosed Sulphadoxine/Pyrimethamine combination. It is expedient to determine if Sulphadoxine/Pyrimethamine is as effective for malaria prophylaxis in pregnant women with sickle cell disease compared with Proguanil. Objective: To compare efficacy of Sulphadoxine/Pyrimethamine with that of Proguanil for malaria prophylaxis in pregnant HbSS women. Study design: This will be a multicentre randomized controlled trial with primary research site at Lagos University Teaching Hospital, Idi-Araba, Lagos, Nigeria. Two Hundred and forty eight (248) consenting pregnant HbSS and HbSC women, randomized into two groups (Sulphadoxine/Pyrimethamine, SP Group and Proguanil, P Group) using computer generated random numbers and who meet the eligibility criteria will be consecutively enrolled in early pregnancy and followed up from booking until discharge from hospital after delivery. Malaria parasitaemia Microscopy and full blood count will be done at booking and at delivery. Polymerase chain reaction (PCR) to detect sub-microscopic parasitaemia in maternal blood at delivery and identify resistant genes in both groups, Cord blood and neonatal blood malaria parasitaemia and placenta histology will also be done following delivery. Cases admitted for febrile illness or sickle cell crises during pregnancy will be screened for malaria by blood film microscopy. Statistical analysis will be done with STATA ver 16
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SPICKLE TRIAL
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 01/01/2021
Actual trial start date 01/01/2021
Anticipated date of last follow up 30/06/2024
Actual Last follow-up date 30/06/2024
Anticipated target sample size (number of participants) 248
Actual target sample size (number of participants) 248
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 created by a computer software program Allocation was determined by the holder of the sequence who is situated off site 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 SP Group Sulphadoxine Pyrimethamine arm three (3) tablets of Sulphadoxine 500mg/Pyrimethamine 25mg will be administered at 16 weeks if the patient booked before then or at any other gestational age thereafter at which the patient booked but from 16 weeks till delivery Each dose of Sulphadoxine/Pyrimethamine will be administered as directly observed therapy (DOT). 124
Control Group P group Proguanil arm Proguanil 200mg daily will be commenced at booking all through till delivery The first dose will be administered as DOT (Directly Observed Therapy) to minimize bias. The participants in Group P will also be asked to bring the packs of their medication for inspection at each antenatal clinic visit and at other times when they present at the hospital, in order to assess and ensure drug compliance. 124 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Pregnant women of all gravidity confirmed as having HbSS genotype. ¿ Screened after 16 weeks or onset of quickening, both aparasitaemic and parasitaemic at first enrolment. ¿ Must give informed written consent. ¿ Known adverse drug reaction to any of the two medications (Sulphadoxine/Pyrimethamine and Proguanil). ¿ Co-existing medical disorders that may alter immunity such as diabetes mellitus (DM) and human immunodeficiency virus infection (HIV). ¿ Multiple gestations. ¿ Presence of severe clinical malaria at booking. ¿ Less than 16 weeks gestational age for Sulphadoxine/Pyrimethamine (SP) group. ¿ Use of antimalarials within the last one week prior to booking. ¿ Refusal to give informed written consent. 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 24/01/2019 LAGOS STATE HOSPITAL MANAGEMENT BOARD ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
LAGOS UNIVERSITY TEACHING HOSPITAL PMB 12003 SURULERE LAGOS NIGERIA LAGOS 101283 Nigeria
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 23/08/2018 Lagos University Teachin Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
PMB 12003 Lagos Lagos 101283 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of malaria parasite at delivery At booking. Whenever the participant develops a febrile illness or sickle cell crisis in pregnancy. Following delivery.
Secondary Outcome incidence of clinical malaria, incidence of malaria complications such as worsening maternal anaemia (haemoglobin concentration <10g/dl) and low birth weight (<2500g), adherence to medications and incidence of adverse drug events. During pregnancy After delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos State University Teaching Hospital (LASUTH) Ikeja Lagos 100282 Nigeria
Ijede General Hospital Ijede, Ikorodu Lagos 104102 Nigeria
Island Maternity Hospital Lagos Island Lagos 100221 Nigeria
Lagos University Teaching Hospital (LUTH) Idi-Araba, Surulere Lagos 101283 Nigeria
Randle General Hospital Randle Road, Surulere Lagos 101283 Nigeria
fako Ijaiye General Hospital Ifako-Ijaiye Lagos 100215 Nigeria
Gbagada General Hospital Gbagada Lagos 100234 Nigeria
Alimosho General Hospital Igando Lagos 100267 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Country Clinical Trials Partnership EDCTP Anna Van Saksenlaan 51 The Hague 2593 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor EDCTP Anna Van Saksenlaan 51 The Hague Netherlands Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Prof. Folasade Ogunsola University of Lagos Akoka Lagos 101283 Nigeria
Dr Lenka Benova Institute of Tropical Medicine, Kronenburgstraat 43 Antwerpen 2000 Netherlands
Prof Titilope Adeyemo Lagos University Teaching Hospital, Idi-Araba Lagos 101283 Nigeria
Prof Dramola Lagos University Teaching Hospital, Idi-Araba Lagos 101283 Nigeria
Dr Adeola Olukosi Nigerian Institute for Medical Research NIMR, Yaba Lagos 101212 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bosede B Afolabi bosedeafolabi2003@yahoo.com +2348023154064 University Teaching Hospital
City Postal code Country Position/Affiliation
Lagos 101283 Nigeria Professor Head Department of Obstetrics and Gynaecology College of Medicine University of Lagos Lagos University Teaching Hospital Idi Araba Lagos Nigeria
Role Name Email Phone Street address
Public Enquiries Ochuwa A. Babah ochuwab@yahoo.co.uk +2348023591137 University Teaching Hospital
City Postal code Country Position/Affiliation
Lagos 101283 Nigeria Senior Lecturer Consultant Obstetrician and Gynaecologist College of Medicine University of Lagos Lagos University Teaching Hospital Idi Araba Lagos Nigeria
Role Name Email Phone Street address
Scientific Enquiries Bosede B. Afolabi bosedeafolabi2003@yahoo.com +2348023154064 University Teaching Hospital
City Postal code Country Position/Affiliation
Lagos 101283 Nigeria Professor Head Department of Obstetrics and Gynaecology College of Medicine University of Lagos Lagos University Teaching Hospital Idi Araba Lagos Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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