- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01103063
Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
May 14, 2015 updated by: Pfizer
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.
Study Overview
Status
Terminated
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
2891
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cotonou, Benin
- Centre de Santé d'AHOUANSORI-AGUE
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Cotonou, Benin
- Hôpital Bethesda
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Siaya, Kenya
- Siaya District Hospital
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Zomba, Malawi
- Zomba Central Hospital
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Mwanza, Tanzania, 1903
- Bugando Medical Centre
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Mwanza, Tanzania
- Nyamagana District Hospital, c/o National Institute for Medical Research, Mwanza Centre
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Mwanza, Tanzania
- Nyamagana District Hospital
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Tanga
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Muheza, Tanga, Tanzania
- Teule Hospital
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Kampala, Uganda
- Mulago Hospital Complex
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 35 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: AZCQ
Azithromycin/chloroquine
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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.
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Active Comparator: SP
sulfadoxine-pyrimethamine (Fansidar)
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population
Time Frame: Approximately 40 weeks of gestational age
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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.
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Approximately 40 weeks of gestational age
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population
Time Frame: Approximately 40 weeks of gestational age
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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.
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Approximately 40 weeks of gestational age
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Percentage of Neonates With LBW (<2500 g) in ITT Population
Time Frame: Approximately 40 weeks of gestational age
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LBW was defined as live birth weight <2500 g (up to and including 2499 g).
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Approximately 40 weeks of gestational age
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Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population
Time Frame: Approximately 40 weeks of gestational age
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LBW was defined as live birth weight <2500 g (up to and including 2499 g).
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Approximately 40 weeks of gestational age
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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.
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Severe maternal anemia was defined as Hb <8 g/dL.
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At 36-38 weeks of gestation.
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Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation
Time Frame: At 36-38 weeks of gestation.
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Anemia was defined as Hb <11 g/dL.
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At 36-38 weeks of gestation.
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Percentage of Participants With Placental Parasitemia at Delivery
Time Frame: Approximately 40 weeks of gestational age
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Participants with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from participants who deliver at hospital.
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Approximately 40 weeks of gestational age
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Percentage of Participants With Placental Malaria at Delivery Based on Histology
Time Frame: Approximately 40 weeks of gestational age
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Participants positive for placental malaria at delivery were evaluated based on placental histology.
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Approximately 40 weeks of gestational age
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Sexually Transmitted Infection (STI) Episodes Per Participant
Time Frame: Approximately 40 weeks of gestational age .
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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).
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Approximately 40 weeks of gestational age .
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Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation
Time Frame: Approximately 40 weeks of gestational age.
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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.
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Approximately 40 weeks of gestational age.
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Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration.
Time Frame: Baseline, at 36-38 weeks of gestation.
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Change from Baseline to 36-38 weeks of gestation in Hb concentration was noted.
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Baseline, at 36-38 weeks of gestation.
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Percentage of Neonates With Congenital Abnormalities at Birth
Time Frame: Approximately 40 weeks of gestational age.
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Neonates with congenital abnormalities at birth were noted.
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Approximately 40 weeks of gestational age.
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Percentage of Perinatal or Neonatal Deaths
Time Frame: Day 28 after delivery.
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Percentage of perinatal or neonatal deaths were noted.
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Day 28 after delivery.
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Birth Weight of Live Borne Neonate
Time Frame: Approximately 40 weeks of gestational age.
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Birth weight of live borne neonates were calculated in grams.
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Approximately 40 weeks of gestational age.
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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
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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.
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Approximately 40 weeks of gestational age
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Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery
Time Frame: Approximately 40 weeks of gestational age
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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).
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Approximately 40 weeks of gestational age
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Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation
Time Frame: At 36-38 weeks of gestation
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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.
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At 36-38 weeks of gestation
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Percentage of Participants With Peripheral Parasitemia at Delivery
Time Frame: Approximately 40 weeks of gestational age
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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.
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Approximately 40 weeks of gestational age
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Percentage of Participants With Cord Blood Parasitemia at Delivery
Time Frame: Approximately 40 weeks of gestational age
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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.
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Approximately 40 weeks of gestational age
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Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation
Time Frame: Upto 36-38 weeks of gestation
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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.
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Upto 36-38 weeks of gestation
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Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation
Time Frame: At 36-38 weeks of gestation
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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.
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At 36-38 weeks of gestation
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Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation
Time Frame: At 36-38 weeks of gestation
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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.
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At 36-38 weeks of gestation
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Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation
Time Frame: At 36-38 weeks of gestation
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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.
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At 36-38 weeks of gestation
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Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation
Time Frame: At 36-38 weeks of gestation
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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.
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At 36-38 weeks of gestation
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Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation.
Time Frame: At 36-38 weeks of gestation
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Bacterial vaginosis was diagnosed based on laboratory result at 36-38 weeks of gestation.
A vaginal swab was collected for the Gram staining.
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At 36-38 weeks of gestation
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Percentage of Neonates With Ophthalmia Neonatorum at Birth Period
Time Frame: Approximately 40 weeks of gestational age
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Ophthalmia neonatorum was diagnosed at birth.
The laboratory diagnosis was performed among neonates with purulent discharge.
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Approximately 40 weeks of gestational age
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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
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Participants positive for bacterial infections including other lower respiratory tract infections were measured anytime from first dose administration to delivery.
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Up to approximately 40 weeks of gestational age
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Percentage of Participants With Pre-eclampsia From Week 20 to Delivery
Time Frame: From Week 20 to approximately 40 weeks of gestational age
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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.
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From Week 20 to approximately 40 weeks of gestational age
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Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae
Time Frame: Visits 6 and 7
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This outcome measure evaluated the Streptococcus pneumoniae sensitivity against macrolide antibiotics.
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Visits 6 and 7
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Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae
Time Frame: Visits 6 and 7
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This outcome measure evaluated the Streptococcus pneumoniae sensitivity against penicillin antibiotics.
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Visits 6 and 7
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Kimani 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
April 7, 2010
First Submitted That Met QC Criteria
April 12, 2010
First Posted (Estimate)
April 13, 2010
Study Record Updates
Last Update Posted (Estimate)
June 16, 2015
Last Update Submitted That Met QC Criteria
May 14, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Malaria, Falciparum
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Amebicides
- Folic Acid Antagonists
- Anti-Infective Agents, Urinary
- Renal Agents
- Chloroquine
- Pyrimethamine
- Azithromycin
- Sulfadoxine
- Fanasil, pyrimethamine drug combination
Other Study ID Numbers
- A0661158
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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