MalariaNCT00287300
Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women
A study testing Sulfadoxine-Pyrimethamine, Azithromycin and Artesunate in people with Malaria, run by University of North Carolina at 1 site in Malawi.
Trial summary
The purpose of this study is to compare the efficacy and safety of three treatment regimens for the prevention of malaria during pregnancy. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Malaria
- What is being tested?
- Sulfadoxine-Pyrimethamine, Azithromycin and Artesunate
- How many people
- 141 participants
- Where
- 1 siteMalawi
- Study dates
- Sep 2003to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- peripheral malaria parasitemia
- signed informed consent
- age 15-49 years
- mother has felt the movements of the foetus (quickening)
- fetal age of at least 14 but not more than 26 completed gestation weeks
- maternal availability for follow-up during the entire period of the study
Who cannot join
- known maternal tuberculosis, diabetes, kidney disease, or liver disease
- mental disorder that may affect comprehension of the study or success of follow-up
- twin pregnancy
- pregnancy complications evident at enrollment visit (moderate to severe oedema, blood Hb concentration < 7 g / dl, systolic blood pressure (BP) > 160 mmHg or diastolic BP > 100 mmHg)
- prior receipt of azithromycin during current pregnancy
- receipt of any antimalarial within 28 days before enrollment
Show all 11Show fewer
- known allergy to drugs containing sulfonamides, macrolides or pyrimethamine
- history of anaphylaxis
- history of any serious allergic reaction to any substance, requiring emergency medical care
- history of hepatitis or jaundice
- concurrent participation in any other clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Controlled Trial of Azithromycin or Artesunate Added to Sulphadoxine Pyrimethamine as Therapy for Malaria in Pregnancy
The purpose of this study is to compare the efficacy and safety of three treatment regimens for the prevention of malaria during pregnancy.
Read the detailed description
Malaria infection during pregnancy poses substantial risk to the mother, her fetus, and the neonate. Prevention of malaria during pregnancy is vital in decreasing maternal and child mortality in Africa. There are data from studies that show that intermittent preventive treatment (IPT) with two doses of sulfadoxine-pyrimethamine (SP) is safe, efficacious, and effective in preventing maternal anemia, placental parasitemia, and LBW. Resistance to SP, however, is increasing rapidly in Africa and there is an urgent need to find alternative effective, safe and affordable drugs for the treatment and prevention of malaria in pregnancy.
The investigators conducted a trial to determine the efficacy and safety of azithromycin and artesunate combined with sulphadoxine-pyrimethamine as treatment against malaria during pregnancy.Pregnant women 14 to 26 weeks gestation with P. falciparum parasitemia on peripheral blood film were randomly assigned into 3 treatment groups and received two doses of:(1) SP (3 tablets) only; (2) SP and azithromycin (1gram/day x 2 days)and (3) SP and artesunate 200mg/day for 3 days). The two doses of the study drug were administered approximately 4 weeks apart. All study drugs were taken under observation.Blood samples were collected on days 1, 2, 3, 7 and 14 after treatment and at any visit when the women presented with symptoms of malaria. The women were also given an insecticide-treated net (ITN) and followed until delivery. Adverse effects were assessed at each scheduled visit, any unscheduled visits during the study, and at delivery. Peripheral and placental blood films and placental biopsies were prepared at delivery. Newborns were weighed, examined, and gestational age was determined.
- Conditions
- Malaria
- Being tested
- Sulfadoxine-Pyrimethamine, Azithromycin, Artesunate
- Keywords
- Malaria, Pregnancy, Efficacy, Azithromycin, Artesunate
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadoxine-PyrimethamineDrug
AzithromycinDrug
ArtesunateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasitological failure rates
Parasite clearance time
Fever clearance times
Incidence rate of adverse events
Secondary outcomes (5)
Prevalence rate of abortions
Prevalence rate of still births
Prevalence rate of peripheral parasitemia at delivery
Prevalence of placental malaria (thick blood film and histology)
Prevalence rate of maternal anemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startSep 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants
Sponsor and investigators
- Lead sponsor
- University of North Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- Steve R Meshnick, M.D., Ph.D., Principal investigator, 2. Department of Epidemiology, School of Public Health, University of North Carolina, Chapel Hill NC USAStephen J Rogerson, MB BS, Ph.D., Principal investigator, 3. Department of Medicine, University of Melbourne, Royal Melbourne Hospital, Parkville Victoria AustraliaMarjorie Chaponda, MB BS, MPH, Principal investigator, 1. UNC Malaria Project, Department of Community Health, College of Medicine, University of Malawi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287300
- Sponsor's protocol ID
- 03-EPID-153
- Status last verified
- Jan 2006
- First submitted
- 3 Feb 2006
- Last updated
- 6 Feb 2006
- Results posted
- No
Publications
Kalilani L, Mofolo I, Chaponda M, Rogerson SJ, Alker AP, Kwiek JJ, Meshnick SR. A randomized controlled pilot trial of azithromycin or artesunate added to sulfadoxine-pyrimethamine as treatment for malaria in pregnant women. PLoS One. 2007 Nov 14;2(11):e1166. doi: 10.1371/journal.pone.0001166.
PubMed 18000538
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of Azithromycin or Artesunate Added to Sulphadoxine Pyrimethamine as Therapy for Malaria in Pregnancy
- ClinicalTrials.gov ID
- NCT00287300
- Acronym / sponsor ID
- 03-EPID-153
- Conditions
- Malaria
- Keywords
- Malaria, Pregnancy, Efficacy, Azithromycin, Artesunate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants
- Lead sponsor
- University of North CarolinaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Sep 2003
- Study completion
- Aug 2005
- First posted
- 6 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and safety of three treatment regimens for the prevention of malaria during pregnancy.
Detailed description
Malaria infection during pregnancy poses substantial risk to the mother, her fetus, and the neonate. Prevention of malaria during pregnancy is vital in decreasing maternal and child mortality in Africa. There are data from studies that show that intermittent preventive treatment (IPT) with two doses of sulfadoxine-pyrimethamine (SP) is safe, efficacious, and effective in preventing maternal anemia, placental parasitemia, and LBW. Resistance to SP, however, is increasing rapidly in Africa and there is an urgent need to find alternative effective, safe and affordable drugs for the treatment and prevention of malaria in pregnancy.
The investigators conducted a trial to determine the efficacy and safety of azithromycin and artesunate combined with sulphadoxine-pyrimethamine as treatment against malaria during pregnancy.Pregnant women 14 to 26 weeks gestation with P. falciparum parasitemia on peripheral blood film were randomly assigned into 3 treatment groups and received two doses of:(1) SP (3 tablets) only; (2) SP and azithromycin (1gram/day x 2 days)and (3) SP and artesunate 200mg/day for 3 days). The two doses of the study drug were administered approximately 4 weeks apart. All study drugs were taken under observation.Blood samples were collected on days 1, 2, 3, 7 and 14 after treatment and at any visit when the women presented with symptoms of malaria. The women were also given an insecticide-treated net (ITN) and followed until delivery. Adverse effects were assessed at each scheduled visit, any unscheduled visits during the study, and at delivery. Peripheral and placental blood films and placental biopsies were prepared at delivery. Newborns were weighed, examined, and gestational age was determined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- peripheral malaria parasitemia
- signed informed consent
- age 15-49 years
- mother has felt the movements of the foetus (quickening)
- fetal age of at least 14 but not more than 26 completed gestation weeks
Key exclusion criteria (11 listed)
- known maternal tuberculosis, diabetes, kidney disease, or liver disease
- mental disorder that may affect comprehension of the study or success of follow-up
- twin pregnancy
- pregnancy complications evident at enrollment visit (moderate to severe oedema, blood Hb concentration < 7 g / dl, systolic blood pressure (BP) > 160 mmHg or diastolic BP > 100 mmHg)
- prior receipt of azithromycin during current pregnancy
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 |
|---|---|---|
| Sulfadoxine-Pyrimethamine | Drug | – |
| Azithromycin | Drug | – |
| Artesunate | Drug | – |
Primary outcome
Parasitological failure rates
Parasite clearance time
Fever clearance times
Incidence rate of adverse events
5 secondary outcomes
Prevalence rate of abortions
Prevalence rate of still births
Prevalence rate of peripheral parasitemia at delivery
Prevalence of placental malaria (thick blood film and histology)
Prevalence rate of maternal anemia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2006.
- Derived from this study: PubMed 18000538Kalilani L, Mofolo I, Chaponda M, Rogerson SJ, Alker AP, Kwiek JJ, Meshnick SR. A randomized controlled pilot trial of azithromycin or artesunate added to sulfadoxine-pyrimethamine as treatment for malaria in pregnant women. PLoS One. 2007 Nov 14;2(11):e1166. doi: 10.1371/journal.pone.0001166.
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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.
Steve R Meshnick, M.D., Ph.D. principal investigator
2. Department of Epidemiology, School of Public Health, University of North Carolina, Chapel Hill NC USA
Stephen J Rogerson, MB BS, Ph.D. principal investigator
3. Department of Medicine, University of Melbourne, Royal Melbourne Hospital, Parkville Victoria Australia
Marjorie Chaponda, MB BS, MPH principal investigator
1. UNC Malaria Project, Department of Community Health, College of Medicine, University of Malawi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulfadoxine-Pyrimethamine, Azithromycin and Artesunate in people with Malaria, run by University of North Carolina at 1 site in Malawi.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 6 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Parasitological failure rates. The study lists 4 primary outcomes in all. 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 NCT00287300, which also lists 1 linked publication.
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 6 Feb 2006.