Randomised Trial of 3 Artemisinin Combination Therapy for Malaria in Pregnancy (DMA)
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| ClinicalTrials.gov Identifier: NCT01054248 |
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Recruitment Status :
Active, not recruiting
First Posted : January 22, 2010
Last Update Posted : September 2, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Malaria | Drug: dihydroartemisinin-piperaquine Drug: Artesunate-mefloquine Drug: arthemeter-lumefantrin | Phase 3 |
The 3 treatment regimens are 3 days of DHA-piperaquine (DP), 3 days of artesunate-mefloquine (MAS3) with mefloquine given as 8,8,8 mg/kg per day and an augmented dose of 4 days (5 tabs BID) of artemether- lumefantrine (ALN+). This will focus on efficacy and safety. Patients will be randomized equally to one of three treatment groups.
Within the trial there are two nested pharmacokinetic studies comprising dense data on 15 women for mefloquine and artesunate and sparse data for mefloquine, lumefantrine and piperaquine. Pregnant women will be followed up until delivery or day 63 if later than delivery and their infants will be followed until the end of the first year of life The follow up of babies will be monthly until 1 year (summarized in the table). Visits will include body weight, length, head circumference, arm circumference, physical examination, motor milestones by observation and caregiver interview, developmental examination and monthly haematocrit and stool testing. The mother is free to bring her infant at any time to the clinic and investigations appropriate to the presenting complaint and symptoms will be carried out as necessary to provide care for the infant.
Infants born to mothers who have a positive peripheral smear at delivery are at risk of congenital malaria and will be actively screened weekly for 2 months. In the last study one congenital malaria P.falciparum occurred at day 21 and the infant was very sick and was cured with artesunate. Infants who are positive for malaria would have a PCR spot to verify if the malaria was congenital.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 499 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomised Open Label Trial Comparing Standard Dose of Dihydroartemisinin-piperaquine, Standard Fixed Artesunate-mefloquine Regimen and a Longer Regimen of Artemether-lumefantrine in the Treatment of Uncomplicated Malaria in Pregnancy |
| Actual Study Start Date : | February 16, 2010 |
| Estimated Primary Completion Date : | January 2021 |
| Estimated Study Completion Date : | January 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: MAS3
Standard three day regimen of artesunate-mefloquine (12/24 mg/kg) given as artesunate 4mg/kg/day and mefloquine 8mg/kg/day on Days 0, 1 and 2.
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Drug: Artesunate-mefloquine
Standard three day regimen of artesunate-mefloquine (12/24 mg/kg) given as artesunate 4mg/kg/day and mefloquine 8mg/kg/day on Days 0, 1 and 2. |
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Active Comparator: ALN+
Augmented 4 day regimen of artemether lumefantrine 2 doses per day for 4 days. Each dose consists of 5 tablets (20/120 mg of artemether/lumefantrine per tablet)
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Drug: arthemeter-lumefantrin
Augmented 4 day regimen of artemether lumefantrine 2 doses per day for 4 days. Each dose consists of 5 tablets (20/120 mg of artemether/lumefantrine per tablet).
Other Name: Coartem |
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Experimental: DP
Standard 3 days regimen DHA-piperaquine: (DHA/PPQ 40 mg/320 mg) 2.4 mg/kg DHA and 20 mg/kg PPQ once daily for 3 days
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Drug: dihydroartemisinin-piperaquine
Standard 3 days regimen DHA-piperaquine: (DHA/PPQ 40 mg/320 mg) 2.4 mg/kg DHA and 20 mg/kg PPQ once daily for 3 days
Other Name: Artekin |
- Cure rate defined as clearance of asexual parasites without recurrence within the period between treatment and delivery or a 63 day period [ Time Frame: Day 63 or until delivery, whichever occurs later ]
- Number of adverse events [ Time Frame: Day 63 ]
- Biochemical and haematological changes [ Time Frame: Day 28 ]
- Kinetic parameters of artesunate, mefloquine, piperaquine and lumefantrine [ Time Frame: Day 42 ]
- Anaemia [ Time Frame: Day 63 ]
- Gametocyte carriage [ Time Frame: Day 63 ]
- Changes in the Reticulocyte counts [ Time Frame: Day 63 ]
- Malaria infection rate at delivery and placental parasitaemia [ Time Frame: Delivery ]
- Pregnancy outcomes (abortions, low birth weight, premature birth, congenital abnormality, stillbirths, neonatal and infant mortality) [ Time Frame: Delivery ]
- Infant growth and development at 1 year of life [ Time Frame: 1 year after delivery ]
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| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18-45 years
- Viable pregnancy of any gestation as assessed by ultrasound scanning
- Microscopically confirmed uncomplicated malaria (parasitaemia ≥ 5/500 WBC) with Plasmodium falciparum or Mixed infection (i.e. P.falciparum & P.vivax/ovale/malariae) or Plasmodium vivax/ovale/malariae
- Willingness and ability to comply with the study protocol for the duration of the trial
- Written informed consent provided
- No signs of labour
Additional criteria for patients in the detailed pharmacokinetic study group (N=24 in the MAS3 arm):
- HCT>25% (based on field reading i.e. capillary sample)
- P.falciparum monoinfection
- Agree to stay in the clinic for 7 days
- Written consent to participate the detailed PK subgroup
Exclusion Criteria:
- Known hypersensitivity to the study drugs
- P.falciparum asexual stage parasitaemia ≥ 4% RBCs
- Clinical or laboratory features of severe malaria based on WHO criteria-Appendix 1
- Gastrointestinal dysfunction that could alter absorption or motility
- History or known liver diseases or other chronic diseases (excluding thalassemia & G6PD deficiency)
- Presence of intercurrent illness or any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study
- Splenectomy
- Hematocrit (HCT) <20% (based on field reading i.e. capillary sample) [ *NB: Dense mefloquine pharmacokinetic exclusion if HCT < 25%]
- Taking contraindicated medications
- History of narcotic or alcohol abuse
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054248
| Thailand | |
| Shoklo Malaria Research Unit | |
| Mae Sot, Tak, Thailand | |
| Principal Investigator: | Rose McGready, MBBS | Shoklo Malaria Research Unit |
| Responsible Party: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT01054248 |
| Other Study ID Numbers: |
SMRU0905 |
| First Posted: | January 22, 2010 Key Record Dates |
| Last Update Posted: | September 2, 2020 |
| Last Verified: | September 2020 |
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pregnancy, malaria, artemisinin, vivax, falciparum |
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Malaria Protozoan Infections Parasitic Diseases Artesunate Piperaquine Dihydroartemisinin Mefloquine Antimalarials |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antineoplastic Agents Antiviral Agents Schistosomicides Antiplatyhelmintic Agents Anthelmintics |