Trial · NCT01103063
Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
NCT01103063, Phase 3, Terminated, Pfizer; results first posted 2014-09-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa. Trials, record NCT01103063. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01103063
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
- NCT number
- NCT01103063
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2,891 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Intermittent Preventive Treatment In Pregnancy (IPTp)
- Interventions
- Azithromycin plus chloroquine, sulfadoxine-pyrimethamine
- First posted
- 2010-04-13
- Last updated
- 2015-06-16
- Results first posted
- 2014-09-05
- Limitations and caveats
This program was terminated by Pfizer based on the results of the pre-planned interim analysis for this pivotal study. The interim analysis showed no benefit of the study drug (AZCQ) compared to standard of care (SP).
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population | 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. |
| Secondary | Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population | Approximately 40 weeks of gestational age | 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. |
| Secondary | Percentage of Neonates With LBW (<2500 g) in ITT Population | Approximately 40 weeks of gestational age | LBW was defined as live birth weight \<2500 g (up to and including 2499 g). |
| Secondary | Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population | Approximately 40 weeks of gestational age | LBW was defined as live birth weight \<2500 g (up to and including 2499 g). |
| Secondary | Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation | At 36-38 weeks of gestation. | Severe maternal anemia was defined as Hb \<8 g/dL. |
| Secondary | Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation | At 36-38 weeks of gestation. | Anemia was defined as Hb \<11 g/dL. |
| Secondary | Percentage of Participants With Placental Parasitemia at Delivery | Approximately 40 weeks of gestational age | Participants with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from participants who deliver at hospital. |
| Secondary | Percentage of Participants With Placental Malaria at Delivery Based on Histology | Approximately 40 weeks of gestational age | Participants positive for placental malaria at delivery were evaluated based on placental histology. |
| Secondary | Sexually Transmitted Infection (STI) Episodes Per Participant | Approximately 40 weeks of gestational age . | 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). |
| Secondary | Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation | Approximately 40 weeks of gestational age. | 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. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population | Approximately 40 weeks of gestational age | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population | Approximately 40 weeks of gestational age | Subset of ITT participants: outcome or withdrawal occurred on or before 8/27/2013 (date of study termination), compliant with study medication, birth weight measured on or before 7 days after birth if not already a failure, and did not switch to standard of care. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Neonates With LBW (<2500 g) in ITT Population | Approximately 40 weeks of gestational age | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Total live births. | Percentage of neonates | NUMBER |
| SECONDARY | Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population | Approximately 40 weeks of gestational age | Subset of ITT participants: outcome or withdrawal occurred on or before 8/27/2013 (date of study termination), compliant with study medication, birth weight measured on or before 7 days after birth if not already a failure, and did not switch to standard of care. N=Total Live Births. | Percentage of neonates | NUMBER |
| SECONDARY | Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation | At 36-38 weeks of gestation. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with Hb measurement at 36-38 weeks gestation. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation | At 36-38 weeks of gestation. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with Hb measurement at 36-38 weeks gestation. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Placental Parasitemia at Delivery | Approximately 40 weeks of gestational age | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with placental parasite counts at delivery. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Placental Malaria at Delivery Based on Histology | Approximately 40 weeks of gestational age | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with a histology parasite evaluation at delivery. | Percentage of participants | NUMBER |
| SECONDARY | Sexually Transmitted Infection (STI) Episodes Per Participant | Approximately 40 weeks of gestational age . | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with available data. | Number of episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation | Approximately 40 weeks of gestational age. | ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Total Outcomes. | Percentage of participants | NUMBER |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population | Azithromycin + Chloroquine | 26.16 | 95% Confidence Interval 23.89 to 28.43 | Percentage of participants | |
| Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population | Sulfadoxine + Pyrimethamine | 23.67 | 95% Confidence Interval 21.48 to 25.86 | Percentage of participants | |
| Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population | Azithromycin + Chloroquine | 10.38 | 95% Confidence Interval 8.57 to 12.19 | Percentage of Participants | |
| Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population | Sulfadoxine + Pyrimethamine | 10.12 | 95% Confidence Interval 8.40 to 11.84 | Percentage of Participants | |
| Percentage of Neonates With LBW (<2500 g) in ITT Population | Azithromycin + Chloroquine | 5.01 | 95% Confidence Interval 3.74 to 6.28 | Percentage of neonates | |
| Percentage of Neonates With LBW (<2500 g) in ITT Population | Sulfadoxine + Pyrimethamine | 5.72 | 95% Confidence Interval 4.40 to 7.04 | Percentage of neonates | |
| Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population | Azithromycin + Chloroquine | 4.72 | 95% Confidence Interval 3.43 to 6.01 | Percentage of neonates | |
| Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population | Sulfadoxine + Pyrimethamine | 5.21 | 95% Confidence Interval 3.92 to 6.50 | Percentage of neonates | |
| Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation | Azithromycin + Chloroquine | 1.80 | 95% Confidence Interval 1.05 to 2.55 | Percentage of participants | |
| Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation | Sulfadoxine + Pyrimethamine | 2.00 | 95% Confidence Interval 1.24 to 2.76 | Percentage of participants |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azithromycin + Chloroquine | 1,446 | |
| Overall Study | STARTED | Sulfadoxine + Pyrimethamine | 1,445 | |
| Overall Study | COMPLETED | Azithromycin + Chloroquine | 969 | |
| Overall Study | COMPLETED | Sulfadoxine + Pyrimethamine | 1,024 | |
| Overall Study | NOT COMPLETED | Azithromycin + Chloroquine | 477 | |
| Overall Study | NOT COMPLETED | Sulfadoxine + Pyrimethamine | 421 |
Source ClinicalTrials.gov
Adverse events540
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Mother (Azithromycin + Chloroquine) | 205 | 1,446 | |
| other | Anaemia | Blood and lymphatic system disorders | Mother (Sulfadoxine + Pyrimethamine) | 192 | 1,445 | |
| other | Anaemia | Blood and lymphatic system disorders | Neonate (Azithromycin + Chloroquine) | 21 | 1,149 | |
| other | Anaemia | Blood and lymphatic system disorders | Neonate (Sulfadoxine + Pyrimethamine) | 14 | 1,196 | |
| other | Vision blurred | Eye disorders | Mother (Azithromycin + Chloroquine) | 145 | 1,446 | |
| other | Vision blurred | Eye disorders | Mother (Sulfadoxine + Pyrimethamine) | 1 | 1,445 | |
| other | Vision blurred | Eye disorders | Neonate (Azithromycin + Chloroquine) | 0 | 1,149 | |
| other | Vision blurred | Eye disorders | Neonate (Sulfadoxine + Pyrimethamine) | 0 | 1,196 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Mother (Azithromycin + Chloroquine) | 123 | 1,446 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Mother (Sulfadoxine + Pyrimethamine) | 50 | 1,445 |
1 to 10 of 540Source ClinicalTrials.gov
See all 540 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mother (Azithromycin + Chloroquine) | ||
| Total, all-cause mortality | Mother (Sulfadoxine + Pyrimethamine) | ||
| Total, all-cause mortality | Neonate (Azithromycin + Chloroquine) | ||
| Total, all-cause mortality | Neonate (Sulfadoxine + Pyrimethamine) | ||
| Total, other adverse events | Mother (Azithromycin + Chloroquine) | 1,177 | 1,446 |
| Total, other adverse events | Mother (Sulfadoxine + Pyrimethamine) | 888 | 1,445 |
| Total, other adverse events | Neonate (Azithromycin + Chloroquine) | 301 | 1,149 |
| Total, other adverse events | Neonate (Sulfadoxine + Pyrimethamine) | 326 | 1,196 |
| Total, serious adverse events | Mother (Azithromycin + Chloroquine) | 65 | 1,446 |
| Total, serious adverse events | Mother (Sulfadoxine + Pyrimethamine) | 42 | 1,445 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01103063
GET https://conductscience.org/api/trials/v1/NCT01103063/registered?page=2