Malaria in PregnancyPhase 3PREGACTNCT00852423
Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria
A Phase 3 study testing Dihydroartemisinin-piperaquine, Artesunate-mefloquine and Artesunate-amodiaquine in people with Malaria in Pregnancy, run by Institute of Tropical Medicine, Belgium at 7 sites in 4 countries.
Trial summary
Malaria is the most important human parasitic disease and is responsible of high morbidity and mortality in resource-poor countries. Pregnant women, who are a high-risk group, are almost always excluded from clinical trials; thus, the investigators lack sufficient information on the safety and efficacy of most… Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Malaria in Pregnancy
- What is being tested?
- Dihydroartemisinin-piperaquine, Artesunate-mefloquine and Artesunate-amodiaquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,428 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Jun 2010to Apr 2015
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestation of at least 16 weeks and <37 weeks;
- P. falciparum monoinfection of any density, with or without symptoms
- Hb equal or higher than 7 g/dL;
- At least 15 years old;
- Residence within the health facility catchment's area;
- Willing to deliver at the health facility;
- Willing to adhere to study requirements (including in Zambia and Malawi, HIV VCT)
- Ability to provide written informed consent; if the woman is minor of age/not emancipated, the consent must be given by a parent or legal guardian according to national law (however, in this case, the investigator is responsible to check that the woman herself is also freely willing to take part in the study, and the woman will be asked to sign for "assent").
Who cannot join
- History of allergic reactions to the study drugs;
- History of known pregnancy complications or bad obstetric history such as repeated stillbirths or eclampsia;
- History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis;
- Current cotrimoxazole prophylaxis or ARV treatment;
- Any significant illness at the time of screening that requires hospitalization, including severe malaria;
- Intent to move out of the study catchment area before delivery or deliver at relative's home out of the catchment area.
Show all 9Show fewer
- Prior enrollment in the study or concurrent enrollment in another study.
- Unable to take oral medication
- Clear evidence of recent (1 week) treatment with antimalarials or antimicrobials with antimalarial activity (clindamycin; azythromycin; etc.)
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Ghana3 sites
Effiduase Government Hospital
Effiduase
Kwame Nkrumah University of Science & Technology, Kumasi
Ejisu Sekyere East, Ashanti Region
Kwame Nrumah University of Science and Technology, Kumasi
Juaben Government Hospital, Ashanti Region
Malawi1 site
College of Medicine, University of Malawi
Chikwawa District Hospital, Blantyre
About this study
Malaria is the most important human parasitic disease and is responsible of high morbidity and mortality in resource-poor countries. Pregnant women, who are a high-risk group, are almost always excluded from clinical trials; thus, the investigators lack sufficient information on the safety and efficacy of most antimalarials in pregnancy. The recommendation of the World Health Organization to use artemisinin combination therapy (ACT) in the 2nd and 3rd trimester is already implemented in several African countries, however documentation of their efficacy and safety in pregnancy is still limited. Thus, the investigators propose to evaluate the efficacy and safety of 4 ACT(artemether-lumefantrine, amodiaquine-artesunate, mefloquine-artesunate and dihydroartemisinin-piperaquine), when used to treat pregnant women with P. falciparum malaria; the results will help to recommend the optimal therapy for this high-risk group in Africa.
Read the detailed description
Malaria is the most important human parasitic disease. Although pregnant women are a high-risk group, they are almost systematically excluded from clinical trials, for fear of teratogenicity and embryotoxicity; thus, we generally lack sufficient information on the safety and efficacy of most antimalarials in pregnancy, as well as evidence-based recommendations for the prevention and treatment of malaria during pregnancy.
The WHO recommendation to use artemisinin combination therapy (ACT) in the 2nd and 3rd trimester is already implemented in several African countries. However, the documentation of their efficacy and safety in pregnancy is still limited, especially concerning the African contexts.
Therefore, we propose to test 4 fixed-dose combinations (artemether-lumefantrine, amodiaquine-artesunate, mefloquine-artesunate and dihydroartemisinin-piperaquine), to evaluate their efficacy and safety when administered to pregnant women (2nd and 3rd trimester) infected with P. falciparum. Explanatory variables will be collected for treatment failure (PCR-corrected) and for recurrent parasitaemia. The primary hypothesis tested will be the clinical equivalence (pair-wise non-inferiority) of the 4 treatment regimens with clinical equivalence defined as difference in treatment failure rates (PCR corrected) of 5% or less.
In addition, an attempt will be done to carry out in vitro testing at the time of recurrent infection. However, the success of the test will depend on the parasite density. In addition, blood samples collected on filter paper at day 0 and at day of recurrent parasitaemia will be genotyped for the search of known molecular markers related to drug resistance. Not all samples will be analyzed; rather these will be selected according to the therapeutic response so that the prevalence of molecular markers will be compared between treatment successes, true treatment failures and new infections.
- Conditions
- Malaria in Pregnancy
- Being tested
- Dihydroartemisinin-piperaquine, Artesunate-mefloquine, Artesunate-amodiaquine, Artemether-lumefantrine
- Keywords
- Malaria in pregnancy, Sub-saharan Africa, Treatment, Artemisinin containing Therapy, Efficacy, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin-piperaquineDrug
Also called DHAPQ, Eurartesim
DHA-PQ tablets are green film coated intended for oral use and contain 20/160mg or 40/320mg of dihydroartemisinin (DHA) and piperaquine phosphate (PQ) respectively. In this trial the 40/320mg for adults will be used. Developed by Sigma Tau in partnership with Medicines for Malaria Venture.
Artesunate-mefloquineDrug
Also called MQAS
MQAS will be provided as a fixed-dose ACT. There are 2 strengths (AS25+MQ55mg and AS100+MQ220mg) and dosing regimen is calculated according to 12 mg/kg AS and 24mg/kgMQ total dose over three days. Pregnant women will receive 2 tablets/day for 3 days. It is developed by Farmanguinhos with the Drugs for Neglected Diseases Initiative. To be noted: if the FDCs will not get the WHO pre-qualification before the start of recruitment, the separate AS and MQ will be used
Artesunate-amodiaquineDrug
Also called AQAS, artesunate-amodiaquine Winthrop®
AQAS, developed by teh DNDi with Sanofi-Aventis and manufactured by Sanofi-Aventis, has been pre-qualified by the WHO in 2008 and is available in several African countries, including those involved in this trial. AQ-AS tablets are round, yellow on one side and white-slightly yellow on the other, with a breaking bar, AS engraved on one side and either 25, 50 or 100 on the other side. Tablets to be used in this trial are those 100mg/270mg AS/AQ, containing 100 mg of artesunate, 352.640 mg of amodiaquine hydrochloride corresponding to 270mg of amodiaquine base.
Artemether-lumefantrineDrug
Also called AL, Coartem, Riamet
AL (tablets containing a FDC of 20 mg of artemether and 120 mg of lumefantrine) is manufactured by Novartis and has been extensively used in Africa for the treatment of uncomplicated malaria. AL was registered in Switzerland in 1999, has since received marketing authorisation in several endemic and non-endemic countries and it is WHO pre-qualified.
| Study group | Role | What they receive |
|---|---|---|
| DHAPQ | Experimental | Three-day treatment with dihydroartemisinin-piperaquine Receives: Drug: Dihydroartemisinin-piperaquine |
| MQAS | Experimental | Three-day treatment with mefloquine artesunate Receives: Drug: Artesunate-mefloquine |
| AQAS | Active comparator | Three-day treatment with artesunate-amodiaquine Receives: Drug: Artesunate-amodiaquine |
| AL | Active comparator | Three day treatment with artemether-lumefantrine (Coartem(R) Receives: Drug: Artemether-lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failure (PCR adjusted)
Measured: Day 63
Safety profiles including significant changes in relevant laboratory values
Measured: Until delivery
Secondary outcomes (10)
Time to failure
Measured: Case by case
PCR unadjusted treatment failure
Measured: Day 63
Gametocyte carriage (gametocyte-weeks)
Measured: Case by case
Asexual parasite clearance time
Measured: Days to 2 consecutive negative blood slides.
Gametocytaemia (prevalence and density)
Measured: Day 7, 14, 21, 28 and 63 after treatment
Haemoglobin changes
Measured: Days 14, 28, 42 and 63
The presence of acute, chronic or past infection of the placenta (prevalence)
Measured: Delivery
Mean birth weight and prevalence of low birth weight newborns
Measured: Delivery
In vitro vitro and search of molecular markers related to drug resistance
Measured: At the time of recurrent infection
Determination of the PK profile of MQ, AQ and PQ (on 120 women/treatment)
Measured: Case by case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startJun 2010
- Primary completionOct 2013
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Malaria in PregnancyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, Kwame Nkrumah University of Science and Technology, Centre Muraz, Kamuzu University of Health Sciences, Tropical Diseases Research Centre, Zambia, Institute of Tropical Medicine(KIT), Amsterdam, Liverpool School of Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Umberto D'Alessandro, MD, Study chair, Institute Tropical Medicine Belgium and MRC Unit in The GambiaTinto Halidou, PharmD, Principal investigator, Centre Muraz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852423
- Sponsor's protocol ID
- ITMP0308
- Acronym
- PREGACT
- Status last verified
- Mar 2016
- First submitted
- 26 Feb 2009
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
PREGACT Study Group; Pekyi D, Ampromfi AA, Tinto H, Traore-Coulibaly M, Tahita MC, Valea I, Mwapasa V, Kalilani-Phiri L, Kalanda G, Madanitsa M, Ravinetto R, Mutabingwa T, Gbekor P, Tagbor H, Antwi G, Menten J, De Crop M, Claeys Y, Schurmans C, Van Overmeir C, Thriemer K, Van Geertruyden JP, D'Alessandro U, Nambozi M, Mulenga M, Hachizovu S, Kabuya JB, Mulenga J. Four Artemisinin-Based Treatments in African Pregnant Women with Malaria. N Engl J Med. 2016 Mar 10;374(10):913-27. doi: 10.1056/NEJMoa1508606.
PubMed 26962727Patson N, Mukaka M, D'Alessandro U, Chapotera G, Mwapasa V, Mathanga D, Kazembe L, Laufer MK, Chirwa T. Joint modelling of multivariate longitudinal clinical laboratory safety outcomes, concomitant medication and clinical adverse events: application to artemisinin-based treatment during pregnancy clinical trial. BMC Med Res Methodol. 2021 Oct 9;21(1):208. doi: 10.1186/s12874-021-01412-9.
PubMed 34627141Nambozi M, Tinto H, Mwapasa V, Tagbor H, Kabuya JB, Hachizovu S, Traore M, Valea I, Tahita MC, Ampofo G, Buyze J, Ravinetto R, Arango D, Thriemer K, Mulenga M, van Geertruyden JP, D'Alessandro U. Artemisinin-based combination therapy during pregnancy: outcome of pregnancy and infant mortality: a cohort study. Malar J. 2019 Mar 28;18(1):105. doi: 10.1186/s12936-019-2737-7.
PubMed 30922317PREGACT Study Group; Pekyi D, Ampromfi AA, Tinto H, Traore-Coulibaly M, Tahita MC, Valea I, Mwapasa V, Kalilani-Phiri L, Kalanda G, Madanitsa M, Ravinetto R, Mutabingwa T, Gbekor P, Tagbor H, Antwi G, Menten J, De Crop M, Claeys Y, Schurmans C, Van Overmeir C, Thriemer K, Van Geertruyden JP, D'Alessandro U, Nambozi M, Mulenga M, Hachizovu S, Kabuya JB, Mulenga J. Four artemisinin-based treatments in African pregnant women with malaria. Malawi Med J. 2016 Sep;28(3):139-149.
PubMed 27895848Tahita MC, Tinto H, Yarga S, Kazienga A, Traore Coulibaly M, Valea I, Van Overmeir C, Rosanas-Urgell A, Ouedraogo JB, Guiguemde RT, van Geertruyden JP, Erhart A, D'Alessandro U. Ex vivo anti-malarial drug susceptibility of Plasmodium falciparum isolates from pregnant women in an area of highly seasonal transmission in Burkina Faso. Malar J. 2015 Jun 20;14:251. doi: 10.1186/s12936-015-0769-1.
PubMed 26088768Nambozi M, Mulenga M, Halidou T, Tagbor H, Mwapasa V, Phiri LK, Kalanda G, Valea I, Traore M, Mwakazanga D, Claeys Y, Schurmans C, De Crop M, Menten J, Ravinetto R, Thriemer K, Van Geertruyden JP, Mutabingwa T, D'Alessandro U; Pregact Group. Safe and efficacious artemisinin-based combination treatments for African pregnant women with malaria: a multicentre randomized control trial. Reprod Health. 2015 Jan 15;12:5. doi: 10.1186/1742-4755-12-5.
PubMed 25592254
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria
- ClinicalTrials.gov ID
- NCT00852423
- Acronym / sponsor ID
- PREGACT / ITMP0308
- Conditions
- Malaria in Pregnancy
- Keywords
- Malaria in pregnancy, Sub-saharan Africa, Treatment, Artemisinin containing Therapy, Efficacy, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,428 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, Kwame Nkrumah University of Science and Technology, Centre Muraz, Kamuzu University of Health Sciences, Tropical Diseases Research Centre, Zambia, Institute of Tropical Medicine(KIT), Amsterdam, Liverpool School of Tropical Medicine
- Study start
- Jun 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 Feb 2009 (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.
Malaria is the most important human parasitic disease and is responsible of high morbidity and mortality in resource-poor countries. Pregnant women, who are a high-risk group, are almost always excluded from clinical trials; thus, the investigators lack sufficient information on the safety and efficacy of most antimalarials in pregnancy. The recommendation of the World Health Organization to use artemisinin combination therapy (ACT) in the 2nd and 3rd trimester is already implemented in several African countries, however documentation of their efficacy and safety in pregnancy is still limited. Thus, the investigators propose to evaluate the efficacy and safety of 4 ACT(artemether-lumefantrine, amodiaquine-artesunate, mefloquine-artesunate and dihydroartemisinin-piperaquine), when used to treat pregnant women with P. falciparum malaria; the results will help to recommend the optimal therapy for this high-risk group in Africa.
Detailed description
Malaria is the most important human parasitic disease. Although pregnant women are a high-risk group, they are almost systematically excluded from clinical trials, for fear of teratogenicity and embryotoxicity; thus, we generally lack sufficient information on the safety and efficacy of most antimalarials in pregnancy, as well as evidence-based recommendations for the prevention and treatment of malaria during pregnancy.
The WHO recommendation to use artemisinin combination therapy (ACT) in the 2nd and 3rd trimester is already implemented in several African countries. However, the documentation of their efficacy and safety in pregnancy is still limited, especially concerning the African contexts.
Therefore, we propose to test 4 fixed-dose combinations (artemether-lumefantrine, amodiaquine-artesunate, mefloquine-artesunate and dihydroartemisinin-piperaquine), to evaluate their efficacy and safety when administered to pregnant women (2nd and 3rd trimester) infected with P. falciparum. Explanatory variables will be collected for treatment failure (PCR-corrected) and for recurrent parasitaemia. The primary hypothesis tested will be the clinical equivalence (pair-wise non-inferiority) of the 4 treatment regimens with clinical equivalence defined as difference in treatment failure rates (PCR corrected) of 5% or less.
In addition, an attempt will be done to carry out in vitro testing at the time of recurrent infection. However, the success of the test will depend on the parasite density. In addition, blood samples collected on filter paper at day 0 and at day of recurrent parasitaemia will be genotyped for the search of known molecular markers related to drug resistance. Not all samples will be analyzed; rather these will be selected according to the therapeutic response so that the prevalence of molecular markers will be compared between treatment successes, true treatment failures and new infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DHAPQ | Experimental | Drug: Dihydroartemisinin-piperaquineThree-day treatment with dihydroartemisinin-piperaquine |
| MQAS | Experimental | Drug: Artesunate-mefloquineThree-day treatment with mefloquine artesunate |
| AQAS | Active comparator | Drug: Artesunate-amodiaquineThree-day treatment with artesunate-amodiaquine |
| AL | Active comparator | Drug: Artemether-lumefantrineThree day treatment with artemether-lumefantrine (Coartem(R) |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Gestation of at least 16 weeks and <37 weeks;
- P. falciparum monoinfection of any density, with or without symptoms
- Hb equal or higher than 7 g/dL;
- At least 15 years old;
- Residence within the health facility catchment's area;
Key exclusion criteria (9 listed)
- History of allergic reactions to the study drugs;
- History of known pregnancy complications or bad obstetric history such as repeated stillbirths or eclampsia;
- History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis;
- Current cotrimoxazole prophylaxis or ARV treatment;
- Any significant illness at the time of screening that requires hospitalization, including severe malaria;
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 |
|---|---|---|
| Dihydroartemisinin-piperaquineAlso: DHAPQ, EurartesimDHA-PQ tablets are green film coated intended for oral use and contain 20/160mg or 40/320mg of dihydroartemisinin (DHA) and piperaquine phosphate (PQ) respectively. In this trial the 40/320mg for adults will be used. Developed by Sigma Tau in partnership with Medicines for Malaria Venture. | Drug | DHAPQ |
| Artesunate-mefloquineAlso: MQASMQAS will be provided as a fixed-dose ACT. There are 2 strengths (AS25+MQ55mg and AS100+MQ220mg) and dosing regimen is calculated according to 12 mg/kg AS and 24mg/kgMQ total dose over three days. Pregnant women will receive 2 tablets/day for 3 days. It is developed by Farmanguinhos with the Drugs for Neglected Diseases Initiative. To be noted: if the FDCs will not get the WHO pre-qualification before the start of recruitment, the separate AS and MQ will be used | Drug | MQAS |
| Artesunate-amodiaquineAlso: AQAS, artesunate-amodiaquine Winthrop®AQAS, developed by teh DNDi with Sanofi-Aventis and manufactured by Sanofi-Aventis, has been pre-qualified by the WHO in 2008 and is available in several African countries, including those involved in this trial. AQ-AS tablets are round, yellow on one side and white-slightly yellow on the other, with a breaking bar, AS engraved on one side and either 25, 50 or 100 on the other side. Tablets to be used in this trial are those 100mg/270mg AS/AQ, containing 100 mg of artesunate, 352.640 mg of amodiaquine hydrochloride corresponding to 270mg of amodiaquine base. | Drug | AQAS |
| Artemether-lumefantrineAlso: AL, Coartem, RiametAL (tablets containing a FDC of 20 mg of artemether and 120 mg of lumefantrine) is manufactured by Novartis and has been extensively used in Africa for the treatment of uncomplicated malaria. AL was registered in Switzerland in 1999, has since received marketing authorisation in several endemic and non-endemic countries and it is WHO pre-qualified. | Drug | AL |
Primary outcome
Treatment Failure (PCR adjusted)
Time frame: Day 63
Safety profiles including significant changes in relevant laboratory values
Time frame: Until delivery
10 secondary outcomes
Time to failure
Time frame: Case by case
PCR unadjusted treatment failure
Time frame: Day 63
Gametocyte carriage (gametocyte-weeks)
Time frame: Case by case
Asexual parasite clearance time
Time frame: Days to 2 consecutive negative blood slides.
Gametocytaemia (prevalence and density)
Time frame: Day 7, 14, 21, 28 and 63 after treatment
Haemoglobin changes
Time frame: Days 14, 28, 42 and 63
The presence of acute, chronic or past infection of the placenta (prevalence)
Time frame: Delivery
Mean birth weight and prevalence of low birth weight newborns
Time frame: Delivery
In vitro vitro and search of molecular markers related to drug resistance
Time frame: At the time of recurrent infection
Determination of the PK profile of MQ, AQ and PQ (on 120 women/treatment)
Time frame: Case by case
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 14 Mar 2016.
- Results publication: PubMed 26962727PREGACT Study Group; Pekyi D, Ampromfi AA, Tinto H, Traore-Coulibaly M, Tahita MC, Valea I, Mwapasa V, Kalilani-Phiri L, Kalanda G, Madanitsa M, Ravinetto R, Mutabingwa T, Gbekor P, Tagbor H, Antwi G, Menten J, De Crop M, Claeys Y, Schurmans C, Van Overmeir C, Thriemer K, Van Geertruyden JP, D'Alessandro U, Nambozi M, Mulenga M, Hachizovu S, Kabuya JB, Mulenga J. Four Artemisinin-Based Treatments in African Pregnant Women with Malaria. N Engl J Med. 2016 Mar 10;374(10):913-27. doi: 10.1056/NEJMoa1508606.
- Derived from this study: PubMed 34627141Patson N, Mukaka M, D'Alessandro U, Chapotera G, Mwapasa V, Mathanga D, Kazembe L, Laufer MK, Chirwa T. Joint modelling of multivariate longitudinal clinical laboratory safety outcomes, concomitant medication and clinical adverse events: application to artemisinin-based treatment during pregnancy clinical trial. BMC Med Res Methodol. 2021 Oct 9;21(1):208. doi: 10.1186/s12874-021-01412-9.
- Derived from this study: PubMed 30922317Nambozi M, Tinto H, Mwapasa V, Tagbor H, Kabuya JB, Hachizovu S, Traore M, Valea I, Tahita MC, Ampofo G, Buyze J, Ravinetto R, Arango D, Thriemer K, Mulenga M, van Geertruyden JP, D'Alessandro U. Artemisinin-based combination therapy during pregnancy: outcome of pregnancy and infant mortality: a cohort study. Malar J. 2019 Mar 28;18(1):105. doi: 10.1186/s12936-019-2737-7.
- Derived from this study: PubMed 27895848PREGACT Study Group; Pekyi D, Ampromfi AA, Tinto H, Traore-Coulibaly M, Tahita MC, Valea I, Mwapasa V, Kalilani-Phiri L, Kalanda G, Madanitsa M, Ravinetto R, Mutabingwa T, Gbekor P, Tagbor H, Antwi G, Menten J, De Crop M, Claeys Y, Schurmans C, Van Overmeir C, Thriemer K, Van Geertruyden JP, D'Alessandro U, Nambozi M, Mulenga M, Hachizovu S, Kabuya JB, Mulenga J. Four artemisinin-based treatments in African pregnant women with malaria. Malawi Med J. 2016 Sep;28(3):139-149.
- Derived from this study: PubMed 26088768Tahita MC, Tinto H, Yarga S, Kazienga A, Traore Coulibaly M, Valea I, Van Overmeir C, Rosanas-Urgell A, Ouedraogo JB, Guiguemde RT, van Geertruyden JP, Erhart A, D'Alessandro U. Ex vivo anti-malarial drug susceptibility of Plasmodium falciparum isolates from pregnant women in an area of highly seasonal transmission in Burkina Faso. Malar J. 2015 Jun 20;14:251. doi: 10.1186/s12936-015-0769-1.
- Derived from this study: PubMed 25592254Nambozi M, Mulenga M, Halidou T, Tagbor H, Mwapasa V, Phiri LK, Kalanda G, Valea I, Traore M, Mwakazanga D, Claeys Y, Schurmans C, De Crop M, Menten J, Ravinetto R, Thriemer K, Van Geertruyden JP, Mutabingwa T, D'Alessandro U; Pregact Group. Safe and efficacious artemisinin-based combination treatments for African pregnant women with malaria: a multicentre randomized control trial. Reprod Health. 2015 Jan 15;12:5. doi: 10.1186/1742-4755-12-5.
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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.
Umberto D'Alessandro, MD study chair
Institute Tropical Medicine Belgium and MRC Unit in The Gambia
Tinto Halidou, PharmD principal investigator
Centre Muraz
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dihydroartemisinin-piperaquine, Artesunate-mefloquine and Artesunate-amodiaquine in people with Malaria in Pregnancy, run by Institute of Tropical Medicine, Belgium at 7 sites in 4 countries.
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 8 inclusion and 9 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 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Ghana, Burkina Faso, Malawi, Zambia. 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?
Treatment Failure (PCR adjusted) (time frame: Day 63). 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 NCT00852423, which also lists 6 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 14 Mar 2016.