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.: PACTR201808177464681 Date of Approval: 21/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Reduction of low birth weight at delivery through the adjunction of oral azithromycin to the intermittent preventive treatment of malaria in pregnant women: a randomized controlled trial in rural Burkina Faso
Official scientific title Reduction of low birth weight at delivery through the adjunction of oral azithromycin to the intermittent preventive treatment of malaria in pregnant women: a randomized controlled trial in rural Burkina Faso
Brief summary describing the background and objectives of the trial This is a phase IV, 2 arms, open label, randomized controlled trial to assess the effect of an adjunctive azithromycin to the routine intermittent preventive treatment of malaria using sulfadoxine pyrimethmine during the second and third trimester of pregnancy on the reduction of the incidence of low birthweight.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ARES URCN 02
Disease(s) or condition(s) being studied Infections and Infestations,Neonatal Diseases,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 01/10/2018
Actual trial start date 13/08/2019
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 942
Actual target sample size (number of participants)
Recruitment status 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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Azithromicyn 3 tablets of sulfadoxine-pyrimethamine (500/25mg) /month starting from the second trimester associated to 4 tablets of azithromycin 500 mg (2 grams) one dose during the second trimester and another during the third trimester. Control :3 tablets of sulfadoxine-pyrimethamine (500/25mg) /month starting from the second trimester From second trimester, monthly till delivery Azithromcyin (AZI) is a semisynthetic azalide macrolide that is structurally related to erythromycin but has a broader spectrum of antibacterial activity, improved tissue penetration and a more favorable pharmacokinetic profile. The antimicrobial spectrum of AZI includes adequate coverage for a variety of organisms such as macrolide-susceptible Chlamydial, Gonorrheal and Treponema species. It is widely used in the treatment of sexually transmitted infections, including those in HIV-infected patients. it will be administered orally associated to sulfadoxine pyrimethamine to reduce the negative effects of malaria and sexually transmitted co-infection on newborn baby. 471
Control Group Sulfadoxine pyrimethamine 3 tablets of sulfadoxine pyrmethamine (500/25mg) at each antenatal care visit starting from the second trimester, given each month until delivery From second trimester till delivery In Burkina Faso, intermittent preventive treatment of malaria during pregnancy using sulfadoxine pyrmethamine is the recommended method of malaria prevention during pregnancy. 471 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Being a pregnant woman between 16 and 32 weeks of pregnancy 2. At least 15 years old; and under 44 years old 3. Residence within the health facility catchment’s area, 4. Willingness to deliver at the health facility; 5. Willingness to adhere to the study protocol requirements; 6. Ability to provide written informed consent. 1. History of allergic reactions to the study drugs; 2. History of known pregnancy complications or bad obstetric history such as repeated stillbirths or eclampsia; 3. History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis; 4. Multiple pregnancies (i.e. twin/triplets); 5. Current cotrimoxazole prophylaxis or anti-retroviral therapy (ART); 6. Any significant ongoing condition that requires hospitalization, including severe malaria; 7. Intent to move out of the study catchment area before delivery or deliver at relative’s home out of the catchment area; 8. Prior enrollment in the study or concurrent enrollment in another study; 9. Unable to take oral medication; 10. Clear evidence of recent treatment with artemisinin based combination treatment (ACT), SP or azithromycin during the first trimester of pregnancy, etc. Adult: 19 Year-44 Year 15 Month(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 19/07/2018 Comite ethique pour la recherche en sante CERS
Ethics Committee Address
Street address City Postal code Country
Ouagadougou Ouagdougou 00226 Burkina Faso
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of low birth weight (birth weight < 2500 g) once, after delivery
Secondary Outcome Number of serious and any adverse events cumulative during pregnancy and neonatal period
Secondary Outcome Percentage of preterm delivered babies Once, after delivery
Secondary Outcome Rate of stillbirth Cumulatively during pregnancy
Secondary Outcome Rate of miscarriage Cumulatively during pregnancy
Secondary Outcome Mean birth weight Once, after delivery
Secondary Outcome Mean duration of gestation Once, after delivery
Secondary Outcome Percentage of low chest circumference at birth Once, after delivery
Secondary Outcome Percentage of low chest or head circumference at birth Once, after delivery
Secondary Outcome Percentage of acute neonate distress Once, after delivery
Secondary Outcome Mean neonate weight gain Once between week 4 and 6 after delivery
Secondary Outcome Mean maternal blood hemoglobin concentration at selection and delivery Twice during antenatal and once at postnatal visit
Secondary Outcome Percentage of women with mild, moderate or severe anemia at each point of hemoglobin assessment Twice during antenatal and once at postnatal visit
Secondary Outcome Percentage of women with peripheral blood malaria parasitaemia and mean parasite density at each month Several times
Secondary Outcome Mean number of maternal illness days during pregnancy and during neonate follow up period Cumulative during pregnancy and neonate follow up period
Secondary Outcome Prevalence of maternal Chlamydia trachomatis, Neisseria gonorrhoea, and Treponema pallidum infection Once at enrollment
Secondary Outcome Incidence of maternal Chlamydia trachomatis, Neisseria gonorrhoea, and vaginal Treponema pallidum infection Cumulatively during pregnancy
Secondary Outcome Prevalence of antibiotics resistant sexually transmitted infection Cumulatively during pregnancy
Secondary Outcome Mean number of neonate illness days Cumulative during neonatal period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Clinical Research Unit of Nanoro CNRST 528, Avenue Kumda-Yoore , BP 218 Ouagadougou CMS 11, Burkina Faso Ouagadougou Burkina Faso
FUNDING SOURCES
Name of source Street address City Postal code Country
Academie de recherche et enseignement superieur Rue Royale 180 Brussels Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor clinical research unit of nanoro CNRST 528, Avenue Kumda-Yoore , BP 218 Ouagadougou CMS 11, Burkina Faso Ouagadougou Burkina Faso Hospital
COLLABORATORS
Name Street address City Postal code Country
Universite Catholique de Louvain B 1348 Louvain-la-Neuve Brussels Belgium
Universite Libre de Bruxelle Avenue Franklin Roosevelt 50 - 1050 Bruxelles Brussels Belgium
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Innocent VALEA innocentvalea@yahoo.fr +22670138271 CNRST 528, Avenue Kumda-Yoore , BP 218 Ouagadougou CMS 11, Burkina Faso
City Postal code Country Position/Affiliation
Nanoro Burkina Faso Researcher at institut de recherche en science de la sante
Role Name Email Phone Street address
Scientific Enquiries Halidou Tinto tintohalidou@gmail.com +22670346354 CNRST 528, Avenue Kumda-Yoore , BP 218 Ouagadougou CMS 11, Burkina Faso
City Postal code Country Position/Affiliation
Ouagadougou Burkina Faso Institut de recherche en science de la sante
Role Name Email Phone Street address
Public Enquiries Seni Kouanda skouanda@irss.bf +22625402675 CNRST 528, Avenue Kumda-Yoore , BP 218 Ouagadougou CMS 11, Burkina Faso
City Postal code Country Position/Affiliation
Ouagadougou Burkina Faso National ethics committee
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