免费获得国外相关药品，最快 1 个工作日回馈药物信息
Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Malaria Prevention in Pregnant Women (IPT-AZ/IPT-SP)
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 |
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 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 |
| 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
|
- 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
- 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
- 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
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
| Contact: Dr Aiyeyemi Adeyinka Joseph, MB;BS, FWACS | 08035057557 | adeyinkaaiyeyemi1@gmail.com | |
| Contact: Dr Eniowo Roland, FMCOG,FWACS | 08033867026 |
| Nigeria | |
| FMCOWO | |
| Owo, Ondo, Nigeria, 341101 | |
| Contact: AHMED Ganiyu Olanipekun, MB;BS 08063458440 ahmadexnatural@gmail.com | |
| Study Director: | Dr Aiyeyemi Adeyinka Joseph, MB;BS, FWACS | Head of Department |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 25, 2019 | ||||||
| First Posted Date ICMJE | May 9, 2019 | ||||||
| Last Update Posted Date | May 10, 2019 | ||||||
| Estimated Study Start Date ICMJE | June 1, 2019 | ||||||
| Estimated Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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
|
||||||
| Original Primary Outcome Measures ICMJE |
Efficacy of sulfadoxine-pyrimethamine and azithromycin in preventing malaria in 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
|
||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures ICMJE |
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
|
||||||
| Original Secondary Outcome Measures ICMJE |
Efficacy of sulfadoxine-pyrimethamine and azithromycin in preventing malaria in pregnancy [ 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
|
||||||
| Current Other Pre-specified Outcome Measures |
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
|
||||||
| Original Other Pre-specified Outcome Measures | Same as current | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Malaria Prevention in Pregnant Women (IPT-AZ/IPT-SP) | ||||||
| Official Title ICMJE | Randomized Controlled Trial of Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Prophylaxis Against Malaria in Pregnancy (IPT) | ||||||
| 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. |
||||||
| 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 Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | 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
|
||||||
| Condition ICMJE |
|
||||||
| Intervention ICMJE |
|
||||||
| Study Arms ICMJE |
|
||||||
| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Unknown status | ||||||
| Estimated Enrollment ICMJE |
168 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | January 31, 2020 | ||||||
| Estimated Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||
| Sex/Gender ICMJE |
|
||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Nigeria | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03944317 | ||||||
| Other Study ID Numbers ICMJE | FMCOWO | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
|
||||||
| IPD Sharing Statement ICMJE |
|
||||||
| Responsible Party | AHMED Ganiyu Olanipekun, Federal Medical Centre, Owo | ||||||
| Study Sponsor ICMJE | Federal Medical Centre, Owo | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
|
||||||
| PRS Account | Federal Medical Centre, Owo | ||||||
| Verification Date | May 2019 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||
