Intermittent Preventive Treatment In Pregnancy (IPTp)Phase 3NCT01103063
Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
A Phase 3 study testing Azithromycin plus chloroquine and sulfadoxine-pyrimethamine in people with Intermittent Preventive Treatment In Pregnancy (IPTp), run by Pfizer at 9 sites in 5 countries.
Trial summary
The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intermittent Preventive Treatment In Pregnancy (IPTp)
- What is being tested?
- Azithromycin plus chloroquine and sulfadoxine-pyrimethamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,891 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Oct 2010to Nov 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women (all gravidae) with ≥14 and ≤26 weeks of gestational age (by ultrasound).
- Evidence of a personally signed and dated informed consent/assent document. Assent will be obtained from subjects <18 years of age.
- Subjects who are willing to and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Subjects who are available for follow up at delivery and on 28 days post delivery.
Who cannot join
- Age <16 years old or >35 years old.
- Multiple gestations as per the ultrasound at screening.
- Clinical symptoms of malaria.
- Hemoglobin < 8 g/dL (at enrollment).
- Any condition requiring hospitalization at enrollment.
- History of convulsions, hypertension, diabetes or any other chronic illness that may adversely affect fetal growth and viability.
Show all 13Show fewer
- Inability to tolerate oral treatment in tablet form.
- Known allergy to the study drugs (azithromycin, chloroquine, and sulfadoxine-pyrimethamine) or to any macrolides or sulphonamides.
- Requirement to use medication during the study that might interfere with the evaluation of the study drug eg, trimethoprim-sulfamethoxazole use in subjects positive for HIV infection.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
- Evidence of current obstetric complications that may adversely impact the pregnancy and/or fetal outcomes, including presence of congenital anomalies, placenta previa or abruption.
- Known severe Sickle Cell (SS) disease or Sickle Hemoglobin C (SC) anemia.
- Known family history of prolonged QT Syndrome, serious ventricular arrhythmia, or sudden cardiac death.
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Tanzania4 sites
Teule Hospital
Muheza, Tanga
Nyamagana District Hospital
Mwanza, Tanzania
Bugando Medical Centre
Mwanza, 1903
Nyamagana District Hospital, c/o National Institute for Medical Research, Mwanza Centre
Mwanza
Benin2 sites
Centre de Santé d'AHOUANSORI-AGUE
Cotonou, Benin
Hôpital Bethesda
Cotonou
About this study
Official title: A Phase 3, Open Label, Randomized, Comparative Study To Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.
Read the detailed description
After interim analysis of efficacy data by an External Data Monitoring Committee, this study was terminated. Investigators were notified on 22 Aug 2013. There were no safety concerns that led to this termination.
- Being tested
- Azithromycin plus chloroquine, sulfadoxine-pyrimethamine
- Keywords
- P. falciparum malaria, IPTp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin plus chloroquineDrug
combination tablet of 250mg azithromycin/155 chloroquine, Once daily PO for three days per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.
sulfadoxine-pyrimethamineDrug
Also called Fansidar
Fansidar tablet (500 mg sulfadoxine /25 mg pyrimethamine), once daily, PO, single dose per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.
| Study group | Role | What they receive |
|---|---|---|
| AZCQ | Experimental | Azithromycin/chloroquine Receives: Drug: Azithromycin plus chloroquine |
| SP | Active comparator | sulfadoxine-pyrimethamine (Fansidar) Receives: Drug: sulfadoxine-pyrimethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population
Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (<2,500 g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
Measured: Approximately 40 weeks of gestational age
Secondary outcomes (29)
Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population
Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with LBW (<2,500g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
Measured: Approximately 40 weeks of gestational age
Percentage of Neonates With LBW (<2500 g) in ITT Population
LBW was defined as live birth weight <2500 g (up to and including 2499 g).
Measured: Approximately 40 weeks of gestational age
Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population
LBW was defined as live birth weight <2500 g (up to and including 2499 g).
Measured: Approximately 40 weeks of gestational age
Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation
Severe maternal anemia was defined as Hb <8 g/dL.
Measured: At 36-38 weeks of gestation.
Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation
Anemia was defined as Hb <11 g/dL.
Measured: At 36-38 weeks of gestation.
Percentage of Participants With Placental Parasitemia at Delivery
Participants with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from participants who deliver at hospital.
Measured: Approximately 40 weeks of gestational age
Percentage of Participants With Placental Malaria at Delivery Based on Histology
Participants positive for placental malaria at delivery were evaluated based on placental histology.
Measured: Approximately 40 weeks of gestational age
Sexually Transmitted Infection (STI) Episodes Per Participant
Number of episodes of sexually transmitted infection episodes per participant were noted. The STI's including Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, from first dose to delivery (diagnosis was based on clinical presentation and lab results).
Measured: Approximately 40 weeks of gestational age .
Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation
Sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight <2,500g), premature birth (<37 weeks), abortion (≤28 weeks), still birth (>28 weeks), neonatal death, congenital malformation, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
Measured: Approximately 40 weeks of gestational age.
Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration.
Change from Baseline to 36-38 weeks of gestation in Hb concentration was noted.
Measured: Baseline, at 36-38 weeks of gestation.
Percentage of Neonates With Congenital Abnormalities at Birth
Neonates with congenital abnormalities at birth were noted.
Measured: Approximately 40 weeks of gestational age.
Percentage of Perinatal or Neonatal Deaths
Percentage of perinatal or neonatal deaths were noted.
Measured: Day 28 after delivery.
Birth Weight of Live Borne Neonate
Birth weight of live borne neonates were calculated in grams.
Measured: Approximately 40 weeks of gestational age.
Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery
This outcome measure determined if an episode of malaria started within the time period of first dose to delivery. Clinical episode of malaria was determined if the participant presented with clinical symptoms of malaria (fever >37.5°C, oral) and diagnosed (either by rapid diagnostic tests or microscopy) with malaria.
Measured: Approximately 40 weeks of gestational age
Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery
This outcome measure evaluated the participants requiring additional treatments for malaria during the study period following the first dose (diagnosed based on clinical presentation and/or lab test results).
Measured: Approximately 40 weeks of gestational age
Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation
This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at 36-38 weeks of gestation. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.
Measured: At 36-38 weeks of gestation
Percentage of Participants With Peripheral Parasitemia at Delivery
This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.
Measured: Approximately 40 weeks of gestational age
Percentage of Participants With Cord Blood Parasitemia at Delivery
This outcome measure evaluated the percentage of participants positive for cord blood parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.
Measured: Approximately 40 weeks of gestational age
Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation
Sexual transmitted disease included Treponema pallidum, Neisseria gonorrhoeae, and Chlamydia trachomatis infections. This was diagnosed based on clinical presentation prior to Week 36-38 and/or lab test results between Week 36-38.
Measured: Upto 36-38 weeks of gestation
Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation
Participants positive for Chlamydia trachomatis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.
Measured: At 36-38 weeks of gestation
Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation
Participants positive for Neisseria gonorrhoeae infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.
Measured: At 36-38 weeks of gestation
Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation
Participants positive for Treponema pallidum infection was diagnosed based on laboratory result at 36-38 weeks of gestation. Treponema Pallidum particle Agglutination Assay was used.
Measured: At 36-38 weeks of gestation
Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation
Participants positive for Trichomonas vaginalis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the laboratory test.
Measured: At 36-38 weeks of gestation
Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation.
Bacterial vaginosis was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the Gram staining.
Measured: At 36-38 weeks of gestation
Percentage of Neonates With Ophthalmia Neonatorum at Birth Period
Ophthalmia neonatorum was diagnosed at birth. The laboratory diagnosis was performed among neonates with purulent discharge.
Measured: Approximately 40 weeks of gestational age
Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery
Participants positive for bacterial infections including other lower respiratory tract infections were measured anytime from first dose administration to delivery.
Measured: Up to approximately 40 weeks of gestational age
Percentage of Participants With Pre-eclampsia From Week 20 to Delivery
Pre-eclampsia was diagnosed as systolic blood pressure of at least 140 mmHg and/or diastolic blood pressure of at least 90 mmHg on two separate readings taken at least 4 hours apart and proteinuria at least 300 mg protein in a 24 hour urine collection.
Measured: From Week 20 to approximately 40 weeks of gestational age
Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae
This outcome measure evaluated the Streptococcus pneumoniae sensitivity against macrolide antibiotics.
Measured: Visits 6 and 7
Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae
This outcome measure evaluated the Streptococcus pneumoniae sensitivity against penicillin antibiotics.
Measured: Visits 6 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2013
- Study completionNov 2013
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intermittent Preventive Treatment In Pregnancy (IPTp)Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,891 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- London School of Hygiene and Tropical Medicine, Medicines for Malaria Venture
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103063
- Sponsor's protocol ID
- A0661158
- Status last verified
- May 2015
- First submitted
- 7 Apr 2010
- Last updated
- 16 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mtove G, Kimani J, Kisinza W, Makenga G, Mangesho P, Duparc S, Nakalembe M, Phiri KS, Orrico R, Rojo R, Vandenbroucke P. Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings. Trials. 2018 Mar 22;19(1):190. doi: 10.1186/s13063-018-2563-1.
PubMed 29566732Kimani J, Phiri K, Kamiza S, Duparc S, Ayoub A, Rojo R, Robbins J, Orrico R, Vandenbroucke P. Efficacy and Safety of Azithromycin-Chloroquine versus Sulfadoxine-Pyrimethamine for Intermittent Preventive Treatment of Plasmodium falciparum Malaria Infection in Pregnant Women in Africa: An Open-Label, Randomized Trial. PLoS One. 2016 Jun 21;11(6):e0157045. doi: 10.1371/journal.pone.0157045. eCollection 2016.
PubMed 27326859
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open Label, Randomized, Comparative Study To Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
- ClinicalTrials.gov ID
- NCT01103063
- Acronym / sponsor ID
- A0661158
- Keywords
- P. falciparum malaria, IPTp
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 2,891 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- London School of Hygiene and Tropical Medicine, Medicines for Malaria Venture
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Posted 5 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.
Detailed description
After interim analysis of efficacy data by an External Data Monitoring Committee, this study was terminated. Investigators were notified on 22 Aug 2013. There were no safety concerns that led to this termination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZCQ | Experimental | Drug: Azithromycin plus chloroquineAzithromycin/chloroquine |
| SP | Active comparator | Drug: sulfadoxine-pyrimethaminesulfadoxine-pyrimethamine (Fansidar) |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pregnant women (all gravidae) with ≥14 and ≤26 weeks of gestational age (by ultrasound).
- Evidence of a personally signed and dated informed consent/assent document. Assent will be obtained from subjects <18 years of age.
- Subjects who are willing to and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Subjects who are available for follow up at delivery and on 28 days post delivery.
Key exclusion criteria (13 listed)
- Age <16 years old or >35 years old.
- Multiple gestations as per the ultrasound at screening.
- Clinical symptoms of malaria.
- Hemoglobin < 8 g/dL (at enrollment).
- Any condition requiring hospitalization at enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin plus chloroquinecombination tablet of 250mg azithromycin/155 chloroquine, Once daily PO for three days per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation. | Drug | AZCQ |
| sulfadoxine-pyrimethamineAlso: FansidarFansidar tablet (500 mg sulfadoxine /25 mg pyrimethamine), once daily, PO, single dose per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation. | Drug | SP |
Primary outcome
Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population
Time frame: Approximately 40 weeks of gestational age
Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (<2,500 g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
29 secondary outcomes
Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population
Time frame: Approximately 40 weeks of gestational age
Percentage of Neonates With LBW (<2500 g) in ITT Population
Time frame: Approximately 40 weeks of gestational age
Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population
Time frame: Approximately 40 weeks of gestational age
Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation
Time frame: At 36-38 weeks of gestation.
Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation
Time frame: At 36-38 weeks of gestation.
Percentage of Participants With Placental Parasitemia at Delivery
Time frame: Approximately 40 weeks of gestational age
Percentage of Participants With Placental Malaria at Delivery Based on Histology
Time frame: Approximately 40 weeks of gestational age
Sexually Transmitted Infection (STI) Episodes Per Participant
Time frame: Approximately 40 weeks of gestational age .
Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation
Time frame: Approximately 40 weeks of gestational age.
Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration.
Time frame: Baseline, at 36-38 weeks of gestation.
Percentage of Neonates With Congenital Abnormalities at Birth
Time frame: Approximately 40 weeks of gestational age.
Percentage of Perinatal or Neonatal Deaths
Time frame: Day 28 after delivery.
Birth Weight of Live Borne Neonate
Time frame: Approximately 40 weeks of gestational age.
Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery
Time frame: Approximately 40 weeks of gestational age
Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery
Time frame: Approximately 40 weeks of gestational age
Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation
Time frame: At 36-38 weeks of gestation
Percentage of Participants With Peripheral Parasitemia at Delivery
Time frame: Approximately 40 weeks of gestational age
Percentage of Participants With Cord Blood Parasitemia at Delivery
Time frame: Approximately 40 weeks of gestational age
Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation
Time frame: Upto 36-38 weeks of gestation
Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation
Time frame: At 36-38 weeks of gestation
Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation
Time frame: At 36-38 weeks of gestation
Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation
Time frame: At 36-38 weeks of gestation
Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation
Time frame: At 36-38 weeks of gestation
Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation.
Time frame: At 36-38 weeks of gestation
Percentage of Neonates With Ophthalmia Neonatorum at Birth Period
Time frame: Approximately 40 weeks of gestational age
Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery
Time frame: Up to approximately 40 weeks of gestational age
Percentage of Participants With Pre-eclampsia From Week 20 to Delivery
Time frame: From Week 20 to approximately 40 weeks of gestational age
Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae
Time frame: Visits 6 and 7
Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae
Time frame: Visits 6 and 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29566732Mtove G, Kimani J, Kisinza W, Makenga G, Mangesho P, Duparc S, Nakalembe M, Phiri KS, Orrico R, Rojo R, Vandenbroucke P. Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings. Trials. 2018 Mar 22;19(1):190. doi: 10.1186/s13063-018-2563-1.
- Derived from this study: PubMed 27326859Kimani J, Phiri K, Kamiza S, Duparc S, Ayoub A, Rojo R, Robbins J, Orrico R, Vandenbroucke P. Efficacy and Safety of Azithromycin-Chloroquine versus Sulfadoxine-Pyrimethamine for Intermittent Preventive Treatment of Plasmodium falciparum Malaria Infection in Pregnant Women in Africa: An Open-Label, Randomized Trial. PLoS One. 2016 Jun 21;11(6):e0157045. doi: 10.1371/journal.pone.0157045. eCollection 2016.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin plus chloroquine and sulfadoxine-pyrimethamine in people with Intermittent Preventive Treatment In Pregnancy (IPTp), run by Pfizer at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Tanzania, Benin, Kenya, Malawi, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population (time frame: Approximately 40 weeks of gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01103063, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.