NCT03944317

Brief Summary

AZITHROMYCIN VERSUS SULPHADOXINE-PYRIMETHAMINE FOR PROPHYLAXIS AGAINST MALARIA IN PREGNANCY IN OWO, SOUIHWESTERN NIGERIA: A RANDOMISED CONTROLLED TRIAL OBJECTIVE: This study is to compare the efficacy of Azithromycin versus sulphadoxine-pyrimethamine as options of chemoprophylaxis against malaria in pregnancy. METHOD: This is a randomized controlled trial with parallel assignment that will be conducted in the Obstetrics and Gynaecology department of the Federal Medical Centre. One hundred and sixty four (164) pregnant women who are eligible will be randomly allocated to 2 groups (A and B) of 84 each, using computer generated random numbers. Group A will receive sulfadoxine-pyrimethamine for malaria prophylaxis while Group B will receive azithromycin. All other aspects of antenatal care till delivery will be the same for all the women recruited. Maternal venous blood samples for malaria parasitaemia will be collected on recruitment and repeated at follow-up visits at any gestation there are symptoms of malaria; maternal peripheral blood film, placental and cord blood samples will be collected at delivery. All data will be documented in the data collection sheet. The results obtained will be subjected to statistical analysis using statistical package for social sciences (SPSS) version 21, Armonk, NY:IBM. The level of significance will be set at 5%. Outcomes will be compared across groups using Chi-square.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

6 months

First QC Date

April 25, 2019

Last Update Submit

May 8, 2019

Conditions

Malaria in PregnancyPregnancy

Keywords

IPTipSPAZ

Outcome Measures

Primary Outcomes (1)

  • malaria parasitaemia during pregnancy

    number of pregnant women with maternal peripheral blood parasitaemia during pregnancy among pregnant women who use sulfadoxine pyrimethamine and azithromycin for malaria prevention in pregnancy

    through study completion, an average of 6 months

Secondary Outcomes (1)

  • malaria parasitaemia at the point of delivery

    at the time of delivery

Other Outcomes (1)

  • low birth weight

    at the time of delivery

Study Arms (2)

Sulfadoxine pyrimethamine

ACTIVE COMPARATOR

SP 1500/75mg tablet orally once starting from 16 weeks, at least at four weekly interval until delivery.

Drug: Sulfadoxine pyrimethamine

Azithromycin

ACTIVE COMPARATOR

A total of 1500mg Azithromycin tablets taken orally as 500mg daily for three consecutive days starting starting from 16weeks of pregnancy and to be repeated once at least after 4 weeks

Drug: Azithromycin

Interventions

Sulfadoxine pyrimethamineDRUG

SP 1500/75mg tablet orally once starting from 16 weeks, at least at four weekly interval until delivery.

Also known as: fansidar
Sulfadoxine pyrimethamine
AzithromycinDRUG

A total of 1500mg Azithromycin tablets taken orally as 500mg daily for three consecutive days starting starting from 16weeks of pregnancy and to be repeated once at least after 4 weeks

Also known as: Zithromax
Azithromycin

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • booked pregnant women
  • Consent for the study
  • Availability for follow-up during the pregnancy by keeping the next ANC appointment
  • Willingness to deliver at the study site
  • Age ≥ 18years
  • comply with use of IPT-SP or Azithromycin medication as required by the study

You may not qualify if:

  • Women treated for malaria in the index pregnancy
  • Women who are severely ill (have medical conditions requiring hospital admission)
  • Women who report prior adverse drug reaction to sulpha-containing medications and Azithromycin
  • Patients with multiple gestations, sickle cell disease, HIV, IUGR and APH
  • Women who did not want to participate in the study
  • Age \<18years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FMCOWO

Owo, Ondo State, 341101, Nigeria

Location

MeSH Terms

Interventions

fanasil, pyrimethamine drug combinationAzithromycin

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Dr Aiyeyemi Adeyinka Joseph, MB;BS, FWACS

    Head of Department

    STUDY DIRECTOR

Central Study Contacts

Dr Aiyeyemi Adeyinka Joseph, MB;BS, FWACS

CONTACT

08035057557adeyinkaaiyeyemi1@gmail.com

Dr Eniowo Roland, FMCOG,FWACS

CONTACT

08033867026

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The personnel involved in the data collection and laboratory staff analyzing the samples will all not be aware of which group of patient is taking SP or Azithromycin
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: The design is a randomized comparative controlled study. Candidates for the study will be recruited from the antenatal booking clinic of our institution after being duly informed that participation is voluntary. Consented eligible pregnant woman will be recruited and those enrolled will be alloted into the two groups A and B of SP and Azithromycin respectively using a computer program (SPSS software version 21, Armonk, NY:IBM) generated sequence of numbers. Sequentially numbered sealed envelope containing either SP or AZ labelled will be allotted one after the other to participants. The personnel involved in the data collection and laboratory staff analyzing the samples will all not be aware of which group of patient is taking SP or Azithromycin while the doctors involved in administering the medication and the patients will be aware of which is being administered.
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2019

First Posted

May 9, 2019

Study Start

June 1, 2019

Primary Completion

November 30, 2019

Study Completion

January 31, 2020

Last Updated

May 10, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

NG(1)