MalariaPhase 4NCT00290420
Prevention of P. Vivax Malaria During Pregnancy in Bolivia
A Phase 4 study testing Chloroquine profilaxis in people with Malaria, run by Institut de Recherche pour le Developpement.
Trial summary
The purpose of this study is to determine which, between weekly prophylaxis or malaria attack treatment, both by chloroquine, is the most appropriate way to protect women and foetus from P. vivax malaria infection during pregnancy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Chloroquine profilaxis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Nov 2007
- Phase
- Phase 4
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnancy between 4 to 36 weeks of gestation
- Intention to deliver at the maternity clinics
- Residence near the maternity clinics
- Written informed consent (parents or tutors if aged<18 years)
Who cannot join
- Pregnancy prior to 4 weeks or after 36 weeks of gestation
- Allergy to chloroquine
- Clinical signs of hepatic or renal alteration
- Inability to take drugs by oral route
- Presence of effective uterine contractions
About this study
Official title: Prevention of P. Vivax Malaria During Pregnancy: Effects on Mother and Child Health in Santa Cruz, Bolivia. Open, Multicentric, Randomized Clinical Trial, Comparing Prophylaxis Once a Week to Malaria Attack Treatment, Both by Chloroquine.
The purpose of this study is to determine which, between weekly prophylaxis or malaria attack treatment, both by chloroquine, is the most appropriate way to protect women and foetus from P. vivax malaria infection during pregnancy.
Read the detailed description
It has been demonstrated that malaria is responsible for anaemia during pregnancy and reduces birth weight among newborns. In Bolivia, malaria is mostly caused by P. vivax. Maternal and foetal consequences of P. vivax infections have been poorly investigated until now, over all in South America. In fact, recommendations for the protection of pregnant women from malaria in Bolivia have not been clearly established. Prophylaxis by chloroquine is still recommended in other continents than Africa, mainly because chloroquine resistances are still uncommon in P. vivax species. The alternative way to protect women during pregnancy is to treat malaria attacks during antenatal visits. For this purpose, we will realize a study in order to assess the most appropriate way to protect women and foetus from malaria infection, i.e. weekly prophylaxis or mild malaria attack treatment, both by chloroquine. By realizing a randomized and multicentric clinical trial on 800 women in each group, we will compare the impact on maternal malaria attack incidence rates, on proportions of mothers with anaemia, on low-birth weight and on positive parasitaemias during pregnancy and at delivery, of weekly prophylaxis and mild malaria attack diagnosis and treatment. The study will be undertaken during 18 months in the region of Santa Cruz and will give important information to the Bolivian Ministry of Health for establishing national recommendations.
- Conditions
- Malaria
- Being tested
- Chloroquine profilaxis
- Keywords
- malaria, Plasmodium vivax, pregnancy, chemoprophylaxis
- Medical subject headings
- Malaria, Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloroquine profilaxisDrug
Also called prevention of plasmodium vivax malaria harmfull effects on birth outcomes
Prevention:
Give a profilaxis with chloroquine once a week to prevent Plasmodium vivax malaria attacks and to prevent harmfull effect on birth outcomes
| Study group | Role | What they receive |
|---|---|---|
| Chloroquine profilaxis | Experimental | Prevention: chloroquine profilaxis
Prevention of malaria attacks with chloroquine profilaxis taken once a week Receives: Drug: Chloroquine profilaxis |
| No prevention | No intervention | Treatment of malaria attack with chloroquine when they occur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of women presenting a malaria attack during pregnancy
Measured: two years
Secondary outcomes (8)
proportions of mothers with placental plasmodial infection
Measured: 2 years
proportions of mothers with moderate to severe anaemia (<8g/dl) at delivery
Measured: 2 years
maternal haemoglobin rate at delivery
Measured: 2 years
proportions of women with parasitaemia during pregnancy and at delivery
Measured: 2 years
mean parasites densities of women with parasitaemia during pregnancy and at delivery
Measured: 2 years
proportions of children with low birthweight (<2,500 grams)
Measured: 2 years
mean birthweight
Measured: 2 years
proportions of preterm deliveries
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionNov 2007 (estimated)
- Study completionNov 2007 (estimated)
Why it stopped: important delays and malaria season missed, due to political changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Instituto Nacional de Laboratorios de Salud (INLASA), Pan American Health Organization, Ministry of Health, Bolivia
- Responsible party
- Principal investigator, Bernadette Murgue, Institut de Recherche pour le Developpement
- Investigators
- Michel Cot, MD-PhD, Study director, Institut de Recherche pour le DeveloppementLaurent Brutus, MD-MSc, Study director, Institut de Recherche pour le Développement, IRD, BoliviaAgnès Le Port, MSc, Principal investigator, Institut de Recherche pour le Développement, IRD, Bolivia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290420
- Sponsor's protocol ID
- IRD/Prevmal/Bol/06
- Status last verified
- May 2013
- First submitted
- 9 Feb 2006
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of P. Vivax Malaria During Pregnancy: Effects on Mother and Child Health in Santa Cruz, Bolivia. Open, Multicentric, Randomized Clinical Trial, Comparing Prophylaxis Once a Week to Malaria Attack Treatment, Both by Chloroquine.
- ClinicalTrials.gov ID
- NCT00290420
- Acronym / sponsor ID
- IRD/Prevmal/Bol/06
- Conditions
- Malaria
- Keywords
- malaria, Plasmodium vivax, pregnancy, chemoprophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: important delays and malaria season missed, due to political changes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- Instituto Nacional de Laboratorios de Salud (INLASA), Pan American Health Organization, Ministry of Health, Bolivia
- Study start
- Mar 2006
- Primary completion
- Nov 2007 (estimated)
- Study completion
- Nov 2007 (estimated)
- First posted
- 13 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 determine which, between weekly prophylaxis or malaria attack treatment, both by chloroquine, is the most appropriate way to protect women and foetus from P. vivax malaria infection during pregnancy.
Detailed description
It has been demonstrated that malaria is responsible for anaemia during pregnancy and reduces birth weight among newborns. In Bolivia, malaria is mostly caused by P. vivax. Maternal and foetal consequences of P. vivax infections have been poorly investigated until now, over all in South America. In fact, recommendations for the protection of pregnant women from malaria in Bolivia have not been clearly established. Prophylaxis by chloroquine is still recommended in other continents than Africa, mainly because chloroquine resistances are still uncommon in P. vivax species. The alternative way to protect women during pregnancy is to treat malaria attacks during antenatal visits. For this purpose, we will realize a study in order to assess the most appropriate way to protect women and foetus from malaria infection, i.e. weekly prophylaxis or mild malaria attack treatment, both by chloroquine. By realizing a randomized and multicentric clinical trial on 800 women in each group, we will compare the impact on maternal malaria attack incidence rates, on proportions of mothers with anaemia, on low-birth weight and on positive parasitaemias during pregnancy and at delivery, of weekly prophylaxis and mild malaria attack diagnosis and treatment. The study will be undertaken during 18 months in the region of Santa Cruz and will give important information to the Bolivian Ministry of Health for establishing national recommendations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroquine profilaxis | Experimental | Drug: Chloroquine profilaxisPrevention: chloroquine profilaxis Prevention of malaria attacks with chloroquine profilaxis taken once a week |
| No prevention | No intervention | –Treatment of malaria attack with chloroquine when they occur |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnancy between 4 to 36 weeks of gestation
- Intention to deliver at the maternity clinics
- Residence near the maternity clinics
- Written informed consent (parents or tutors if aged<18 years)
Key exclusion criteria (5 listed)
- Pregnancy prior to 4 weeks or after 36 weeks of gestation
- Allergy to chloroquine
- Clinical signs of hepatic or renal alteration
- Inability to take drugs by oral route
- Presence of effective uterine contractions
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 |
|---|---|---|
| Chloroquine profilaxisAlso: prevention of plasmodium vivax malaria harmfull effects on birth outcomesPrevention: Give a profilaxis with chloroquine once a week to prevent Plasmodium vivax malaria attacks and to prevent harmfull effect on birth outcomes | Drug | Chloroquine profilaxis |
Primary outcome
Incidence of women presenting a malaria attack during pregnancy
Time frame: two years
8 secondary outcomes
proportions of mothers with placental plasmodial infection
Time frame: 2 years
proportions of mothers with moderate to severe anaemia (<8g/dl) at delivery
Time frame: 2 years
maternal haemoglobin rate at delivery
Time frame: 2 years
proportions of women with parasitaemia during pregnancy and at delivery
Time frame: 2 years
mean parasites densities of women with parasitaemia during pregnancy and at delivery
Time frame: 2 years
proportions of children with low birthweight (<2,500 grams)
Time frame: 2 years
mean birthweight
Time frame: 2 years
proportions of preterm deliveries
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
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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.
Michel Cot, MD-PhD study director
Institut de Recherche pour le Developpement
Laurent Brutus, MD-MSc study director
Institut de Recherche pour le Développement, IRD, Bolivia
Agnès Le Port, MSc principal investigator
Institut de Recherche pour le Développement, IRD, Bolivia
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chloroquine profilaxis in people with Malaria, run by Institut de Recherche pour le Developpement.
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 5 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: withdrawn, as of the sponsor's last update on 22 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of women presenting a malaria attack during pregnancy (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2013.