Trial · NCT01103713
Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa
NCT01103713, Phase 3, Terminated, Pfizer; results first posted 2015-01-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa. Trials, record NCT01103713. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01103713
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa
- NCT number
- NCT01103713
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 168 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Asymptomatic Parasitemia In Pregnancy
- Interventions
- Azithromycin plus chloroquine
- First posted
- 2010-04-15
- Last updated
- 2015-01-26
- Results first posted
- 2015-01-26
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication | Day 28 | The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure. |
| Primary | Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication | Day 28 | The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure. |
| Secondary | Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication | Days 7, 14, 21, 35, and 42 | The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure. |
| Secondary | Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication | Days 7, 14, 21, 35, and 42 | The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure. |
| Secondary | Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | Days 7, 14, 21, 28, 35, and 42 | The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure. |
| Secondary | Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | Days 7, 14, 21, 28, 35, and 42 | The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure. |
| Secondary | Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | Days 7, 14, 21, 28, 35, and 42 | Parasite counts (actual counts per microliter of blood) was measured at various time points. |
| Other | Summary of Pregnancy Outcome: Location of Delivery | Following delivery or pregnancy termination | All participants were followed up for exposure-in-utero (EIU) safety assessments following delivery or termination of pregnancy. |
| Other | Summary of Pregnancy Outcome: Mode of Delivery | Following delivery or pregnancy termination | All participants were followed up for EIU safety assessments following delivery or termination of pregnancy. |
| Other | Summary of Pregnancy Outcome: Delivery Assisted by Trained Obstetric Personnel? | Following delivery or pregnancy termination | All participants were followed up for EIU safety assessments following delivery or termination of pregnancy. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication | Day 28 | MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication | Day 28 | PP population was used. PP is a subset of MITT population who had received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication | Days 7, 14, 21, 35, and 42 | MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication | Days 7, 14, 21, 35, and 42 | PP population was used. PP is a subset of MITT population who had received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | Days 7, 14, 21, 28, 35, and 42 | ITT population was used. ITT is defined as all participants who received at least one dose of study medication and who had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | Days 7, 14, 21, 28, 35, and 42 | MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | Days 7, 14, 21, 28, 35, and 42 | PP population was used. PP is a subset of MITT population who received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | Days 7, 14, 21, 28, 35, and 42 | ITT population was used. ITT is defined as all participants who received at least one dose of study medication and had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Percentage of participants | NUMBER |
| SECONDARY | Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | Days 7, 14, 21, 28, 35, and 42 | ITT population was used. ITT is defined as all participants who received at least one dose of study medication and had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Parasite count per microliter | MEAN |
| SECONDARY | Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | Days 7, 14, 21, 28, 35, and 42 | MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Parasite count per microliter | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication | Azithromycin (AZ)/Chloroquine (CQ) | 99.35 | 95% Confidence Interval 97.76 to 100.00 | Percentage of participants | |
| Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication | Azithromycin (AZ)/Chloroquine (CQ) | 99.35 | 95% Confidence Interval 97.76 to 100.00 | Percentage of participants | |
| Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication | Azithromycin/Chloroquine (AZCQ) | Day 7 (n=156) | 100 | 95% Confidence Interval 97.66 to 100.00 | Percentage of participants |
| Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication | Azithromycin/Chloroquine (AZCQ) | Day 14 (n=154) | 100 | 95% Confidence Interval 97.63 to 100.00 | Percentage of participants |
| Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication | Azithromycin/Chloroquine (AZCQ) | Day 21 (n=154) | 100 | 95% Confidence Interval 97.63 to 100.00 | Percentage of participants |
| Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication | Azithromycin/Chloroquine (AZCQ) | Day 35 (n=148) | 96.65 | 95% Confidence Interval 93.42 to 99.87 | Percentage of participants |
| Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication | Azithromycin/Chloroquine (AZCQ) | Day 42 (n=138) | 95.19 | 95% Confidence Interval 91.35 to 99.03 | Percentage of participants |
| Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication | Azithromycin (AZ)/Chloroquine (CQ) | Day 7 (n=156) | 100.00 | 95% Confidence Interval 97.66 to 100.00 | Percentage of participants |
| Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication | Azithromycin (AZ)/Chloroquine (CQ) | Day 14 (n=154) | 100.00 | 95% Confidence Interval 97.63 to 100.00 | Percentage of participants |
| Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication | Azithromycin (AZ)/Chloroquine (CQ) | Day 21 (n=154) | 100.00 | 95% Confidence Interval 97.63 to 100.00 | Percentage of participants |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azithromycin (AZ)/Chloroquine (CQ) | 168 | |
| Overall Study | COMPLETED | Azithromycin (AZ)/Chloroquine (CQ) | 155 | |
| Overall Study | NOT COMPLETED | Azithromycin (AZ)/Chloroquine (CQ) | 13 |
Source ClinicalTrials.gov
Adverse events86
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 | Azithromycin/Chloroquine (Familial Status = Neonate) | 0 | 157 | |
| other | Anaemia | Blood and lymphatic system disorders | Azithromycin/Chloroquine (Familial Status = Mother) | 1 | 168 | |
| other | Vision blurred | Eye disorders | Azithromycin/Chloroquine (Familial Status = Neonate) | 0 | 157 | |
| other | Vision blurred | Eye disorders | Azithromycin/Chloroquine (Familial Status = Mother) | 1 | 168 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Azithromycin/Chloroquine (Familial Status = Neonate) | 0 | 157 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Azithromycin/Chloroquine (Familial Status = Mother) | 2 | 168 | |
| other | Abdominal pain | Gastrointestinal disorders | Azithromycin/Chloroquine (Familial Status = Neonate) | 0 | 157 | |
| other | Abdominal pain | Gastrointestinal disorders | Azithromycin/Chloroquine (Familial Status = Mother) | 1 | 168 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Azithromycin/Chloroquine (Familial Status = Neonate) | 0 | 157 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Azithromycin/Chloroquine (Familial Status = Mother) | 1 | 168 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azithromycin/Chloroquine (Familial Status = Neonate) | ||
| Total, all-cause mortality | Azithromycin/Chloroquine (Familial Status = Mother) | ||
| Total, other adverse events | Azithromycin/Chloroquine (Familial Status = Neonate) | 20 | 157 |
| Total, other adverse events | Azithromycin/Chloroquine (Familial Status = Mother) | 92 | 168 |
| Total, serious adverse events | Azithromycin/Chloroquine (Familial Status = Neonate) | 9 | 157 |
| Total, serious adverse events | Azithromycin/Chloroquine (Familial Status = Mother) | 0 | 168 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Azithromycin/Chloroquine (Familial Status = Neonate) vs Azithromycin/Chloroquine (Familial Status = Mother): serious adverse events |
Source Trial comparisons
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/NCT01103713
GET https://conductscience.org/api/trials/v1/NCT01103713/outcomes?page=2