Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Malaria Prevention in Pregnant Women (IPT-AZ/IPT-SP)

• ClinicalTrials.gov Identifier: NCT03944317
• Recruitment Status: Unknown
• First Posted: May 9, 2019
• Last Update Posted: May 10, 2019
• Sponsor: Federal Medical Centre, Owo
• Information provided by (Responsible Party): AHMED Ganiyu Olanipekun, Federal Medical Centre, Owo

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Malaria in Pregnancy; Pregnancy	Drug: Sulfadoxine pyrimethamine; Drug: Azithromycin	Not Applicable

Detailed Description:

Study design and Patient recruitment

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. Informed consent will be obtained after the purpose, procedure, benefits, discomfort, risks and precautions associated with the study have been dully explained to them. Due diligence will be taken in adequately responding to any question or concern raised about the study. It will fully be explained to them that their participation is entirely voluntary. Also, if they are unwilling at any point to participate, they will be completely at liberty to discontinue their participation in the study which will not in any away affect their further and adequate management in the hospital. It will be explained that their participation in the study will not have any negative impact on them and their unborn babies and it has no financial benefits but the outcomes of the study may contribute to improved antenatal care. However, if there is additional financial cost (though not immediately foreseen) to any patient outside the cost of routine ANC visit, the investigator shall arrange for modest compensation. 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: 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.
• Masking: Single (Outcomes Assessor)
• Masking Description: 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
• Primary Purpose: Prevention
• Official Title: Randomized Controlled Trial of Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Prophylaxis Against Malaria in Pregnancy (IPT)
• Estimated Study Start Date: June 1, 2019
• Estimated Primary Completion Date: November 30, 2019
• Estimated Study Completion Date: January 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Sulfadoxine pyrimethamine; SP 1500/75mg tablet orally once starting from 16 weeks, at least at four weekly interval until delivery.	Drug: Sulfadoxine pyrimethamine; SP 1500/75mg tablet orally once starting from 16 weeks, at least at four weekly interval until delivery.; Other Name: fansidar
Active Comparator: Azithromycin; 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; 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; Other Name: Zithromax

Outcome Measures

Primary Outcome Measures :

1. malaria parasitaemia during pregnancy [ Time Frame: through study completion, an average of 6 months ]
   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

Secondary Outcome Measures :

1. malaria parasitaemia at the point of delivery [ Time Frame: at the time of delivery ]
   number of pregnant women with maternal peripheral blood and placental parasitaemia, number of new born with cord blood parasitaemia at birth among pregnant women who use sulfadoxine pyrimethamine and azithromycin for malaria prevention in pregnancy

Other Outcome Measures:

1. low birth weight [ Time Frame: at the time of delivery ]
   number of low birthweight babies among pregnant women who use sulfadoxine pyrimethamine and azithromycin for malaria prevention in pregnancy

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: Dr Aiyeyemi Adeyinka Joseph, MB;BS, FWACS; 08035057557; adeyinkaaiyeyemi1@gmail.com

Contact: Dr Eniowo Roland, FMCOG,FWACS; 08033867026

Locations

Nigeria

FMCOWO

Owo, Ondo, Nigeria, 341101

Contact: AHMED Ganiyu Olanipekun, MB;BS 08063458440 ahmadexnatural@gmail.com

Sponsors and Collaborators

Federal Medical Centre, Owo

Investigators

• Study Director: Dr Aiyeyemi Adeyinka Joseph, MB;BS, FWACS; Head of Department

More Information

• Responsible Party: AHMED Ganiyu Olanipekun, Principal Investigator, Federal Medical Centre, Owo
• ClinicalTrials.gov Identifier: NCT03944317
• Other Study ID Numbers: FMCOWO
• First Posted: May 9, 2019
• Last Update Posted: May 10, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by AHMED Ganiyu Olanipekun, Federal Medical Centre, Owo:

IPTip; SP; AZ

Additional relevant MeSH terms:

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Azithromycin; Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Folic Acid Antagonists; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Urinary; Renal Agents