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.: PACTR202305696485090 Date of Approval: 12/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sulfadoxine Pyrimethamine with Azithromycin versus Sulfadoxine Pyrimethamine alone for malaria chemoprophylaxis in pregnancy
Official scientific title A comparison of the efficacy of sulfadoxine pyrimethamine with azithromycin versus sulfadoxine pyrimethamine alone for malaria chemoprophylaxis in pregnancy: A triple blind randomized control trial.
Brief summary describing the background and objectives of the trial Malaria in pregnancy is a major cause of maternal and perinatal morbidity and mortality in Nigeria and Sub Saharan Africa. The current drug widely used for chemoprophylaxis is Sulfadoxine Pyrimethamine (SP) but there is increasing evidence of resistance in many parts of Africa. Consequently, studies have explored the suitability of other drugs as possible alternatives including Sulfadoxine Pyrimethamine and Azithromycin combination (SPAZ). The objective of this study will be to compare the efficacy of SPAZ to SP alone as chemoprophylactic agent against Malaria in pregnancy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/05/2023
Actual trial start date
Anticipated date of last follow up 27/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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
Control Group Sulfadoxine Pyrimethamine plus placebo 1500mg of Sulfadoxine, 75mg of Pyrimethamine and a placebo taken as a stat dose from the second trimester 1500mg of Sulfadoxine, 75mg of pyrimethamine and a placebo taken at 4weekly interval till delivery The participants will commence the drug use from early second trimester and using the current WHO guidelines. The drugs will be in the custody of the hospital Pharmacist, who will give the drugs to the participants in either group using the computer generated numbers. The drugs will be removed from their conventional drug sachets (to ensure participants are blinded) and placed in a drug dispensing envelope. Either envelope will contain four tablets. For the SP group, three tablets comprising Sulfadoxine 500mg, Pyrimethamine 25mg and a placebo tablet (the placebo for this study is a combination of lactose and maize and will have an exact physical appearance of the Azithromycin used in this study). 50 Active-Treatment of Control Group
Experimental Group Sulfadoxine Pyrimethamine with Azithromycin 1500mg Sulfadoxine and 75mg Pyrimethamine with 500mg Azithromycin at intervals of 4weekly From early second trimester at 4weekly intervals till delivery. For the Sulfadoxine Pyrimethamine with Azithromycin group, three tablets of SP (1500mg/75mg) and one tablet of 500mg Azithromycin will be administered at an interval of 4weekly from early second trimester till delivery 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Booked Ante Natal patient in Federal Medical Centre, Asaba, Delta state - Willingness to provide informed consent - Gestational age greater than or equal to 13 weeks - Known drug allergy to Sulfadoxine Pyrimethamine - Known drug allergy to Azithromycin - Multiple Gestation - Clinical signs/ symptoms of Malaria - Laboratory positive blood film for Malaria parasite - Packed Cell Volume less than 30% - Sickle Cell Disease - Human Immunodeficiency Infection Adult: 19 Year-44 Year 19 Year(s) 44 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 25/10/2022 Research and Ethics Committee of the Federal Medical Centre Asaba
Ethics Committee Address
Street address City Postal code Country
Nnebisi Road Asaba Asaba, Delta State Nigeria 320107 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Present of Malaria parasites in the mother, fetus and placenta at delivery At delivery
Secondary Outcome Maternal packed cell volume, and fetal birth weight At delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Asaba Nnebisi Road, Asaba Asaba Delta State Nigeria Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Robinson Ogwu Airport View Estate Okpanam Asaba Asaba 320108 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Robinson Ogwu Airport view Estate,Okpanam Asaba 320108 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Peter Ndidi Ebeigbe Ugbowo Road Benin Nigeria
Dr. Jombo Sunday Emmanuel Asaba Benin Expressway Asaba Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Robinson Ogwu robinsonogwu80@gmail.com +2348023764840 4 Onyelukachukwu street , airport view estate, Okpanam
City Postal code Country Position/Affiliation
Asaba Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Robinson Ogwu robinsonogwu@gmail.com +2348023764840 4 Onyelukachukwu street, Airport view Estate, Okpanam
City Postal code Country Position/Affiliation
Asaba Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Peter Ebeigbe peternebeigbe@gmail.com +2348035649146 Ugbowo road, Benin City, Edo state
City Postal code Country Position/Affiliation
Benin Nigeria Professor of Obstetrics and Gynaecology and Consultant Obstericians and Gynaecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Patient Data (IPD) will be shared after de-identification of all data collected Informed Consent Form,Statistical Analysis Plan,Study Protocol February 2024 to June 2024 Open
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