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.: PACTR201701001982152 Date of Approval: 18/01/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of Sulphadoxine-Pyrimethamine versus Dihydroartemisinin-Piperaquine for Intermittent Preventive Therapy of Pregnancy-associated Malaria
Official scientific title Efficacy of Sulphadoxine-Pyrimethamine versus Dihydroartemisinin-Piperaquine for Intermittent Preventive Therapy of Pregnancy-associated Malaria
Brief summary describing the background and objectives of the trial Pregnancy-associated malaria (PAM) is a major public health issue due to significant adverse maternal and fetal health effects. Parasite resistance (P. falciparum) to Sulphadoxine-Pyrimethamine (SP) has emerged in Africa, hence this project aims to determine if Dihydroartemisinin-Piperaquine is a comparable substitute for SP for malaria prevention in pregnancy in Nigeria,considering current drug efficacy and occurrence of adverse effects.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ESDIPAM
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 01/04/2018
Actual trial start date 01/04/2018
Anticipated date of last follow up 30/09/2020
Actual Last follow-up date 30/09/2020
Anticipated target sample size (number of participants) 350
Actual target sample size (number of participants) 350
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 Permuted block randomization in blocks of 10, size not variable Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dihydroartemisinin-Piperaquine Dihydroartemisinin 40mg, Piperaquine 320mg fixed dose combination, one tablet daily fpr three days given twice: 16-24weeks, then 28-34weeks gestation Each tablet given daily for 3 days at 16-24weeks, then repeated once at 28-34weeks gestation Artemisinin Combination Therapy (ACT) antimalarial 175
Control Group Sulphadoxine-Pyrimethamine Sulphadoxine 500mg, Pyrimethamine 25mg fixed dose combination, three tablets given at once, repeated once during the pregnancy First dose at 16-24weeks, repeat at 28-34weeks Standard antimalarial for Intermittent Preventive Therapy of Malaria in Pregnancy 175 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women ¿18years old, 16-28weeks gestational age at enrollment, living within the study vicinity and willing to deliver at the study site facility, had no anti-malarial,tetracycline or sulphonamide-derivative drugs within the preceding seven days,who give consent. Pregnant women who do not meet the inclusion criteria, HIV-positive women, hypersensitivity to any of the study drugs. 18 Year(s) 60 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
No 01/02/2017 Babcock University Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ilishan road Ilishan-Remo 220001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome -Prevalence of placental malaria diagnosed histopathologically by parasite presence At delivery of baby
Primary Outcome -Incidence of maternal malaria infection by day 28 post-IPT diagnosed by clinical and parasitological methods Day 28 post-IPT administration
Secondary Outcome Incidence of: maternal anemia,spontaneous miscarriage,preterm delivery,low birth weight,still birth,congenital anomalies,neonatal death - maternal anemia: Day 28 post-IPT 1 and IPT 2, at delivery, day 42 post delivery - Spontaneous miscarriage: 16 weeks -27weeks+6days gestational age - Preterm delivery: 28weeks - 36weeks+6days gestational age - birth weight,still birth,congenital anomalies: At delivery of baby - Neonatal death: Day 0-28 following birth
Secondary Outcome -Prevalence of resistance markers on molecular analysis Day 0,7,28 & 42 post-IPT1 and IPT2, at delivery, Day 42 post-delivery
Secondary Outcome -Plasma drug concentration Day 28 & 42 post-IPT
Secondary Outcome -Drug tolerability and incidence of adverse events Day 0-42 post-IPT administration
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ilishan Primary Health Centre, Maternity Unit Ayegbami road Ilishan-Remo 220001 Nigeria
Ikenne Ward 2 Primary Health Centre Ikenne road Ikenne 220001 Nigeria
Department of Obs & Gynae, Babcock University Teaching Hospital Ilishan road Ilishan-Remo 220001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Babcock University Ilishan road Ilishan-Remo 220001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Babcock University Ilishan road Ilishan-Remo Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Olaleye Atinuke Babcock University, Ilishan road Ilishan-Remo Nigeria
Walker Oladapo Babcock University, Ilishan road Ilishan-Remo Nigeria
Uyaiabasi Noblefather Babcock University, Ilishan road Ilishan-Remo Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Atinuke Olaleye tinukeolaleye@gmail.com 08033511909 Ilishan road
City Postal code Country Position/Affiliation
Ilishan-Remo Nigeria Lecturer/Consultant OBGYN, Babcock University
Role Name Email Phone Street address
Public Enquiries Oladapo Walker oladapo.walker@gmail.com +234 8129438279 Babcock University, Ilishan road
City Postal code Country Position/Affiliation
Ilishan-Remo Nigeria Professor of Pharmacology, Babcock University
Role Name Email Phone Street address
Scientific Enquiries Atinuke Olaleye tinukeolaleye@gmail.com 08033511909 Ilishan road
City Postal code Country Position/Affiliation
Ilishan-Remo Nigeria Lecturer/Consultant OBGYN, Babcock University
REPORTING
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