Malaria, FalciparumPhase 3NCT00142207
Preventing Malaria During Pregnancy in Epidemic-prone Areas.
A Phase 3 study testing Intermittent preventive treatment:sulphadoxine-pyrimethamine and Insecticide-treated mosquito bed net in people with Malaria, Falciparum, run by London School of Hygiene and Tropical Medicine at 1 site in Uganda.
Trial summary
The purpose of this study is to compare the efficacy and cost-effectiveness of three alternative strategies for the prevention of malaria during pregnancy in an epidemic-prone area of low transmission in the East African Highlands. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Intermittent preventive treatment:sulphadoxine-pyrimethamine and Insecticide-treated mosquito bed net
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,775 participants
- Where
- 1 siteUganda
- Study dates
- Jan 2004to Jan 2007
- Phase
- Phase 3
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women whose pregnancies are at <27 weeks gestation at first antenatal booking
- Permanent resident in study area
- Informed consent
Who cannot join
- Late presentation: pregnancies more than 26 weeks gestation at first antenatal booking
- Severe anaemia (Hb<70g/L) on enrolment
- Previous reaction to a sulfa-drug (e.g. sulphadoxine-pyrimethamine, septrin)
- History of severe skin reaction to any drug
- Current (or history) of severe disease (e.g. hepatitis, jaundice, TB, AIDS)
- Withdrawal Criteria:
- Withdrawal of consent
- Women developing severe anaemia (Hb<70g/L)during pregnancy
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Kabale District Health Services (antenatal clinics at selected sites)
Kabale, Kabale District
About this study
Official title: The Efficacy and Cost-effectiveness of Malaria Prevention in Pregnancy in an Area of Low and Unstable Transmission in Kabale, Uganda: Use of Intermittent Preventive Treatment and Insecticide-treated Nets.
The purpose of this study is to compare the efficacy and cost-effectiveness of three alternative strategies for the prevention of malaria during pregnancy in an epidemic-prone area of low transmission in the East African Highlands.
The strategies being compared are:
Read more
- intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP)
- an insecticide treated net (ITN), and
- intermittent preventive treatment with SP plus an ITN
In addition to the main individually-randomised trial, outcome data was subsequently also gathered on pregnant women whose houses where sprayed with indoor residual insecticides (IRS) as part of a non-randomised district-wide control programme to compare the impact of IRS with the three intervention arms.
Read the detailed description
Susceptibility to malaria infection during pregnancy and the severity of clinical manifestation are determined by the level of pre-pregnancy immunity, which depends on intensity and stability of malaria transmission. Most intervention trials to prevent malaria during pregnancy have been conducted in areas of intense transmission. The results of trials conducted in high-transmission areas may not be applicable to low transmission areas, where malaria is less frequent but the risk of spontaneous abortion and stillbirth is very high in women of all parities due to lack of sufficient malaria immunity. Routine chemoprophylaxis is generally not recommended in areas of unstable malaria transmission. However, intermittent treatment with an effective anti-malarial drug may be beneficial, especially during periods of malaria transmission. Little work has been carried out amongst pregnant women living in areas of low and unstable transmission in Africa. No data are available on the cost-effectiveness of malaria control in low transmission settings.
This study will compare the efficacy and cost effectiveness of three preventive strategies for the control of malaria during pregnancy in low-transmission settings. The study is located in Kabale district, a highland area in SW Uganda.
Women attending antenatal care are randomised to receive either:
- intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP)
- an insecticide treated net (ITN), or
- intermittent preventive treatment with SP and an ITN. It is hypothesized that when combined with IPT-SP, the additional impact of ITNs by reducing exposure may be greatest where the intensity of transmission is low.
In addition to the main individually-randomised trial, outcome data was subsequently also gathered on pregnant women whose houses where sprayed with indoor residual insecticides (IRS) as part of a non-randomised district-wide control programme to compare the impact of IRS with the three intervention arms.
The study aims to identify the most effective intervention strategies suited to areas characterised by low and unstable transmission. Research findings should be applicable to other hypoendemic areas of the East African highlands.
- Conditions
- Malaria, Falciparum
- Being tested
- Intermittent preventive treatment:sulphadoxine-pyrimethamine, Insecticide-treated mosquito bed net
- Keywords
- malaria, pregnancy, intermittent preventive treatment, insecticide-treated nets
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent preventive treatment:sulphadoxine-pyrimethamineDrug
Two doses given twice during pregnancy (once in the second trimester, and once in the third trimester). Oral medication in tablet form: single daily dose given on each occasion
Insecticide-treated mosquito bed netDevice
Insecticide-treated mosquito bed net
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine Receives: Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine |
| 2 | Active comparator | Device: Insecticide-treated mosquito bed net Receives: Device: Insecticide-treated mosquito bed net |
| 3 | Active comparator | Combination of Drug + Device:
Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine Device: Insecticide-treated mosquito bed net Receives: Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine; Device: Insecticide-treated mosquito bed net |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean birthweight
Measured: April 2004-Jan 2007
prevalence of low birthweight
Measured: April 2004 - Jan 2007
Secondary outcomes (3)
maternal anaemia - mean Hb at gestational age 36 weeks, prevalence of Hb<100g/L at gestational age 36 weeks
Measured: Feb 2003 - Jan 2007
spontaneous abortions
Measured: Feb 2003 - Jan 2007
stillbirths
Measured: April 2003-Jan 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malaria, FalciparumStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,775 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Uganda
- Responsible party
- Principal investigator, Brian Greenwood, London School of Hygiene and Tropical Medicine
- Investigators
- Richard H Ndyomugyenyi, MBChB, PhD, Principal investigator, Vector Control Division, Ministry of Health, UgandaSian E Clarke, PhD, Principal investigator, London School of Hygiene and Tropical Medicine, University of London, UKPascal Magnussen, MD, Principal investigator, DBL - Institute for Health Research and Development, DenmarkKristian Schultz Hansen, PhD, Principal investigator, DBL - Institute for Health Research and Development, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142207
- Sponsor's protocol ID
- ITDCVG32
- Status last verified
- Jan 2017
- First submitted
- 31 Aug 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ndyomugyenyi R, Clarke S, Chandramohan D, Twesigomwe T & Magnussen P. (2005). Epidemiology of pregnancy-associated malaria in the Ugandan highlands [abstract]. Acta Tropica, Suppl 95: S448.
Hansen KS, Ndyomugyenyi R, Magnussen P, Clarke SE. Cost-effectiveness analysis of three health interventions to prevent malaria in pregnancy in an area of low transmission in Uganda. Int Health. 2012 Mar;4(1):38-46. doi: 10.1016/j.inhe.2011.10.001.
PubMed 24030879Ndyomugyenyi R, Clarke SE, Hutchison CL, Hansen KS, Magnussen P. Efficacy of malaria prevention during pregnancy in an area of low and unstable transmission: an individually-randomised placebo-controlled trial using intermittent preventive treatment and insecticide-treated nets in the Kabale Highlands, southwestern Uganda. Trans R Soc Trop Med Hyg. 2011 Nov;105(11):607-16. doi: 10.1016/j.trstmh.2011.07.012. Epub 2011 Oct 2.
PubMed 21962292
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Cost-effectiveness of Malaria Prevention in Pregnancy in an Area of Low and Unstable Transmission in Kabale, Uganda: Use of Intermittent Preventive Treatment and Insecticide-treated Nets.
- ClinicalTrials.gov ID
- NCT00142207
- Acronym / sponsor ID
- ITDCVG32
- Conditions
- Malaria, Falciparum
- Keywords
- malaria, pregnancy, intermittent preventive treatment, insecticide-treated nets
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,775 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Ministry of Health, Uganda
- Study start
- Jan 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 2 Sep 2005 (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 cost-effectiveness of three alternative strategies for the prevention of malaria during pregnancy in an epidemic-prone area of low transmission in the East African Highlands.
The strategies being compared are:
- intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP)
- an insecticide treated net (ITN), and
- intermittent preventive treatment with SP plus an ITN
In addition to the main individually-randomised trial, outcome data was subsequently also gathered on pregnant women whose houses where sprayed with indoor residual insecticides (IRS) as part of a non-randomised district-wide control programme to compare the impact of IRS with the three intervention arms.
Detailed description
Susceptibility to malaria infection during pregnancy and the severity of clinical manifestation are determined by the level of pre-pregnancy immunity, which depends on intensity and stability of malaria transmission. Most intervention trials to prevent malaria during pregnancy have been conducted in areas of intense transmission. The results of trials conducted in high-transmission areas may not be applicable to low transmission areas, where malaria is less frequent but the risk of spontaneous abortion and stillbirth is very high in women of all parities due to lack of sufficient malaria immunity. Routine chemoprophylaxis is generally not recommended in areas of unstable malaria transmission. However, intermittent treatment with an effective anti-malarial drug may be beneficial, especially during periods of malaria transmission. Little work has been carried out amongst pregnant women living in areas of low and unstable transmission in Africa. No data are available on the cost-effectiveness of malaria control in low transmission settings.
This study will compare the efficacy and cost effectiveness of three preventive strategies for the control of malaria during pregnancy in low-transmission settings. The study is located in Kabale district, a highland area in SW Uganda.
Women attending antenatal care are randomised to receive either:
- intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP)
- an insecticide treated net (ITN), or
- intermittent preventive treatment with SP and an ITN. It is hypothesized that when combined with IPT-SP, the additional impact of ITNs by reducing exposure may be greatest where the intensity of transmission is low.
In addition to the main individually-randomised trial, outcome data was subsequently also gathered on pregnant women whose houses where sprayed with indoor residual insecticides (IRS) as part of a non-randomised district-wide control programme to compare the impact of IRS with the three intervention arms.
The study aims to identify the most effective intervention strategies suited to areas characterised by low and unstable transmission. Research findings should be applicable to other hypoendemic areas of the East African highlands.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamineDrug: Intermittent preventive treatment:sulphadoxine-pyrimethamine |
| 2 | Active comparator | Device: Insecticide-treated mosquito bed netDevice: Insecticide-treated mosquito bed net |
| 3 | Active comparator | Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine, Device: Insecticide-treated mosquito bed netCombination of Drug + Device: Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine Device: Insecticide-treated mosquito bed net |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women whose pregnancies are at <27 weeks gestation at first antenatal booking
- Permanent resident in study area
- Informed consent
Key exclusion criteria (8 listed)
- Late presentation: pregnancies more than 26 weeks gestation at first antenatal booking
- Severe anaemia (Hb<70g/L) on enrolment
- Previous reaction to a sulfa-drug (e.g. sulphadoxine-pyrimethamine, septrin)
- History of severe skin reaction to any drug
- Current (or history) of severe disease (e.g. hepatitis, jaundice, TB, AIDS)
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 |
|---|---|---|
| Intermittent preventive treatment:sulphadoxine-pyrimethamineTwo doses given twice during pregnancy (once in the second trimester, and once in the third trimester). Oral medication in tablet form: single daily dose given on each occasion | Drug | 1, 3 |
| Insecticide-treated mosquito bed netInsecticide-treated mosquito bed net | Device | 2, 3 |
Primary outcome
mean birthweight
Time frame: April 2004-Jan 2007
prevalence of low birthweight
Time frame: April 2004 - Jan 2007
3 secondary outcomes
maternal anaemia - mean Hb at gestational age 36 weeks, prevalence of Hb<100g/L at gestational age 36 weeks
Time frame: Feb 2003 - Jan 2007
spontaneous abortions
Time frame: Feb 2003 - Jan 2007
stillbirths
Time frame: April 2003-Jan 2007
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 12 Jan 2017.
- BackgroundNdyomugyenyi R, Clarke S, Chandramohan D, Twesigomwe T & Magnussen P. (2005). Epidemiology of pregnancy-associated malaria in the Ugandan highlands [abstract]. Acta Tropica, Suppl 95: S448.
- Derived from this study: PubMed 24030879Hansen KS, Ndyomugyenyi R, Magnussen P, Clarke SE. Cost-effectiveness analysis of three health interventions to prevent malaria in pregnancy in an area of low transmission in Uganda. Int Health. 2012 Mar;4(1):38-46. doi: 10.1016/j.inhe.2011.10.001.
- Derived from this study: PubMed 21962292Ndyomugyenyi R, Clarke SE, Hutchison CL, Hansen KS, Magnussen P. Efficacy of malaria prevention during pregnancy in an area of low and unstable transmission: an individually-randomised placebo-controlled trial using intermittent preventive treatment and insecticide-treated nets in the Kabale Highlands, southwestern Uganda. Trans R Soc Trop Med Hyg. 2011 Nov;105(11):607-16. doi: 10.1016/j.trstmh.2011.07.012. Epub 2011 Oct 2.
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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.
Richard H Ndyomugyenyi, MBChB, PhD principal investigator
Vector Control Division, Ministry of Health, Uganda
Sian E Clarke, PhD principal investigator
London School of Hygiene and Tropical Medicine, University of London, UK
Pascal Magnussen, MD principal investigator
DBL - Institute for Health Research and Development, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intermittent preventive treatment:sulphadoxine-pyrimethamine and Insecticide-treated mosquito bed net in people with Malaria, Falciparum, run by London School of Hygiene and Tropical Medicine at 1 site in Uganda.
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 3 inclusion and 8 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 12 Jan 2017. 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 Uganda. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
mean birthweight (time frame: April 2004-Jan 2007). The study lists 2 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 NCT00142207, which also lists 3 linked publications.
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 12 Jan 2017.