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Efficacy,Safety and Tolerability of Dihydroartemisinin-Piperaquine for Uncomplicated Malaria in Pregnancy in Ghana (DHAPPQ/MIP)

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ClinicalTrials.gov Identifier: NCT01231113
Recruitment Status : Completed
First Posted : November 1, 2010
Last Update Posted : February 24, 2016
Sponsor:
Collaborator:
Malaria Capacity Development Consortium
Information provided by (Responsible Party):
Joseph Osarfo, Kwame Nkrumah University of Science and Technology

Study Description
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Brief Summary:

Malaria in pregnancy poses enormous public health challenges, contributing to significant maternal and infant deaths yearly. Adverse outcomes include maternal anaemia and low birthweight. Down regulation of cellular immunity increases pregnant women's susceptibility to malaria and mediate these adverse outcomes.

The World Health Organization recommends treatment with artemisinin-combination therapy. Ghana uses quinine for malaria in first trimester pregnancies while artesunate-amodiaquine (AS-AQ) and quinine again are used in later trimesters. Recent amendments added artesunate-lumefantrine and dihydroartemisinin-piperaquine (DHA-PPQ) to the antimalarials used in the country. A high degree of safety and efficacy of DHA-PPQ is documented in several studies. DHA-PPQ, though not specified for use in pregnancy as of now, is accessible and available following its inclusion in the national malaria guidelines and may inadvertently be used to treat malaria in pregnancy. Paucity of data on DHA-PPQ use in pregnancy makes it pertinent to study its safety, tolerability and efficacy in pregnancy.

We propose an open label, randomized controlled non-inferiority comparison of DHA-PPQ and AS-AQ for treatment of uncomplicated malaria in pregnancy in second and third trimesters to assess safety, tolerability and efficacy of DHA-PPQ. Outcomes of interest include PCR-corrected cure rates at days 28 and 42, maternal haemoglobin levels at days 14 and 42, prevalence of congenital abnormalities and pregnancy wastage. Proportions and percentages will be described at 95% Confidence Intervals and compared using chi-square tests. Parametric and non-parametric tests of significance will be applied as appropriate to determine significance of differences in outcomes between the treatment groups.


Condition or disease Intervention/treatment Phase
Pregnancy Complicated by Malaria as Antepartum Condition Drug: artesunate-amodiaquine Drug: Dihydroartemisinin-piperaquine Phase 3

Detailed Description:

Pregnant women of all ages, gravidity and with gestational ages 16-30 weeks, living within 15 km of the study center and presenting for antenatal care or diagnosed with uncomplicated malaria will be screened with P.falciparum rapid diagnostic test kits after obtaining consent. Those testing positive will have blood film microscopy done and only those with positive blood film microscopy will be recruited to participate in the study. Participants will be randomized to receive either dihydroartemisinin-piperaquine at an estimated total dosing of 6.75mg/kg of dihydroartemisinin and 55mg/kg of piperaquine for 3 days rounded to the nearest half tablet) or artesunate-amodiaquine(artesunate 4mg/kg and amodiaquine 10mg/kg in two twelve hourly doses daily for 3 days) after giving informed consent and a physical examination. This will be followed by home visits on days 1, 3, 7, 14, 28 and 42 post-treatment to assess occurrence of adverse events and to obtain blood samples for microscopy, filter paper blots for PCR analysis and haematology. The mentioned laboratory investigations will also be conducted at recruitment.

Participants will be followed up to delivery and 6 weeks post-partum to gather data on maternal peripheral and placental parasitaemia, cord parasitaemia, maternal haemoglobin levels, low birth weights, stillbirths, preterm deliveries, neonatal jaundice, birth defects and infant deaths.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 417 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Tolerability of Dihydroartemisinin-Piperaquine for Treatment of Uncomplicated Falciparum Malaria in Pregnancy: an Open-label, Randomised Controlled, Non-inferiority Trial
Study Start Date : July 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria Pregnancy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: artesunate-amodiaquine arm
A co-blistered pack of amodiaquine and artesunate.The 452 pregnant women in this arm will receive artesunate-amodiaquine tablets(artesunate 4mg/kg and amodiaquine 10mg/kg in twelve hourly doses over 3 days
 Drug: artesunate-amodiaquine
The 452 pregnant women in this arm will receive artesunate-amodiaquine tablets(artesunate 4mg/kg and amodiaquine 10mg/kg in twelve hourly doses over 3 days
Other Name: camosunate
Experimental: Dihydroartemisinin-piperaquine arm
a fixed-dose combination to be administered to the other 452 pregnant women in this arm at an estimated total dosing of 6.75mg/kg dihydroartemisinin and 55mg/kg piperaquine over 3 days
 Drug: Dihydroartemisinin-piperaquine
a fixed-dose combination to be administered to the other 452 pregnant women in this arm at an estimated total dosing of 6.75mg/kg dihydroartemisinin and 55mg/kg piperaquine over 3 days
Other Name: artekin


Outcome Measures
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Primary Outcome Measures :
  1. PCR-corrected parasitological cure rates at days 28 and 42 [ Time Frame: 42-day follow-up ]

    Only eligible subjects with positive falciparum rapid diagnostic test results and positive blood films on microscopy will be recruited. Filter paper blots will be prepared at recruitment as well.

    Blood films and filter paper blots will be repeated on days 3,7,14,28 and 42 post-first dose of treatment.

    PCR analysis will be conducted on only those follow-ups with positive blood films



Secondary Outcome Measures :
  1. prevalence of birth defects [ Time Frame: assessment made 24-72 hours post-partum ]
    birth defects obvious on inspection

  2. Comparative prevalence of adverse and serious adverse events [ Time Frame: three-monthly and at end of study ]
    the data monitoring committee will assess adverse events data quarterly and advice accordingly. Where there is no justification to stop the study before completion, the final assessments will done on study completion

  3. pregnancy outcomes (spontaneous abortions, still births, preterm delivery, etc) [ Time Frame: quaterly from first recorded delivery and on completion ]
    data monitoring committee will assess generated data on the above and advice accordingly


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • RDT positive + microscopy confirmed P. falciparum parasitaemia. ii) Informed consent. iii) Resident within the defined 15km radius of the study center. iv) No history of antimalarial treatment in the preceding two weeks. v) Assurance of adherence to study requirements, follow-up and delivery at the hospital.

vi) Haemoglobin ≥ 7g/dl.

Exclusion Criteria:

  • i) Confirmed multiple gestation. ii) Severe malaria or disease likely to influence pregnancy outcome eg renal/ cardiac disease, diabetes mellitus, known pregnancy induced hypertension, known human immunodeficiency virus infection.

iii) Known allergies to study medication. iv) Antimalarial treatment administered by a third party during the follow-up.

Contacts and Locations
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Information from the National Library of Medicine

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): NCT01231113


Locations
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Ghana
St.Michael's Hospital, Pramso
Kumasi, Ashanti Region, Ghana
Sponsors and Collaborators
Kwame Nkrumah University of Science and Technology
Malaria Capacity Development Consortium
Investigators
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Principal Investigator: Joseph Osarfo, MBCHB, MPH Malaria Capacity Development Consortium-Ghana, Department of Community Health, School of Medical Science, Kwame Nkrumah University of Science and Technology
Study Director: Harry Tagbor, PhD Kwame Nkrumah University of Science and Technology
Study Director: Pascal Magnussen DBL-University of Copenhagen
More Information
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Additional Information:

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Responsible Party: Joseph Osarfo, Principal Investigator, Kwame Nkrumah University of Science and Technology
ClinicalTrials.gov Identifier: NCT01231113    
Other Study ID Numbers: version 8/DHAPPQ/MIP
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Keywords provided by Joseph Osarfo, Kwame Nkrumah University of Science and Technology:
malaria,
pregnancy,
dihydroartemisinin-piperaquine,
 efficacy,
safety,
Ghana
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases
Artesunate
Piperaquine
Amodiaquine
Artenimol
 Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics