Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR2010020001429343 Date of Approval: 02/02/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EVALUATION OF THE SAFETY AND EFFICACY OF MEFLOQUINE AS INTERMITTENT PREVENTIVE TREATMENT FOR MALARIA IN PREGNANCY
Official scientific title EVALUATION OF THE SAFETY AND EFFICACY OF MEFLOQUINE AS INTERMITTENT PREVENTIVE TREATMENT FOR MALARIA IN PREGNANCY
Brief summary describing the background and objectives of the trial The spread of parasite resistance to SP, particularly in eastern Africa, and the significant overlap in some regions of malaria transmission and high prevalence of HIV infection, have raised concerns about the medium and long-term use of SP for IPTp. The evaluation of alternative antimalarials for IPTp is thus urgently needed. The study aims at comparing the safety, tolerability and efficacy of Mefloquine (MQ) to Sulfadoxine-Pyrimethamine (SP) as IPTp
Type of trial CCT
Acronym (If the trial has an acronym then please provide) MiPPAD
Disease(s) or condition(s) being studied Infections and Infestations,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 24/09/2009
Actual trial start date
Anticipated date of last follow up 23/09/2010
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Drug administration: Mefloquine (split dose) MQ oral administration (15 mg/kg) split dose over 2 days at the 1st and 2nd ANC visit as IPTp pregnancy Trial 1: IPTp-MQ (split dose)+LLITNs: ExperimentalHIV-negative pregnant women receiving 2 doses of MQ as IPTp split dose over 2 days (15mg/kg) in the context of long lasting insecticide treated nets (LLITNs 1572
Experimental Group Drug administration: Mefloquine (full dose) MQ oral administration (15 mg/Kg) at the 1st and 2nd Antenatal Clinic visit as IPTp pregnancy Trial 1: IPTp-MQ (full dose) + LLITNs: Experimental. HIV-negative pregnant women receiving 2 full doses of IPTp (15 mg/Kg) in the context of long lasting Insecticide Treated Nets (LLITNs) 1572
Control Group Drug administration: Sulphadoxine-pyrimethamine SP oral administration (500mg sulphadoxine and 25mg pyrimethamine) as IPTp at the 1st and 2nd Antenatal Clinic visit pregnancy Trial 1: IPTp-SP+LLITNs: Active Comparator.HIV-negative pregnant women receiving 2 doses of IPTp (500mg of sulfadoxine and 25 mg of pyrimethamine) in the context of long lasting Insecticide Treated Nets (LLITNs) 1572 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Permanent resident in the area Gestational age at the first antenatal visit < 28 weeks Signed informed consent Agreement to deliver in the study site's maternity wards Residence outside the study area or planning to move out in the following 18 months from enrollment Gestational age at the first antenatal visit > 28 weeks of pregnancy Known history of allergy to sulfa drugs or mefloquine Known history of severe renal, hepatic, psychiatric or neurological disease MQ or halofantrine treatment in the preceding 4 weeks HIV infection Participating in other studies 15 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/09/2008 Hospital clinic Ethics Committee for Clinical Trials
Ethics Committee Address
Street address City Postal code Country
Villaroel 170 Barcelona 08036 Spain
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/11/2008 CERIL
Ethics Committee Address
Street address City Postal code Country
Lambarene Gabon
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/05/2008 CNBS
Ethics Committee Address
Street address City Postal code Country
Maputo Mozambique
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/12/2008 NRB
Ethics Committee Address
Street address City Postal code Country
Dar es Salaam Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/01/2009 NERB
Ethics Committee Address
Street address City Postal code Country
Nairobi Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/10/2009 CE
Ethics Committee Address
Street address City Postal code Country
Cotonou Benin
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Prevalence of low borth weight (<2500 kg) Delivery
Secondary Outcome Prevalence of placental P. falciparum infection Delivery
Secondary Outcome Prevalence of moderate maternal anaemia at delivery Delivery
Secondary Outcome Prevalence of severe maternal anaemia at delivery Delivery
Secondary Outcome Mean maternal hemoglobin rate Pregnancy
Secondary Outcome Peripheral maternal parasitaemia Delivery
Secondary Outcome Prevalence of P.falciparum in cord blood Delivery
Secondary Outcome Prevalence of fetal anaemia Delivery
Secondary Outcome Incidence of vomiting Pregnancy
Secondary Outcome Incidence of dizziness Pregnancy
Secondary Outcome Mean birth weight Delivery
Secondary Outcome Prevalence of prematurity Delivery
Secondary Outcome Number of stillbirths Delivery
Secondary Outcome Number of miscarriages Pregnancy
Secondary Outcome Mean gestational age Pregnancy
Secondary Outcome Incidence of clinical malaria Pregnancy
Secondary Outcome Incidence of overall admissiojns/outpatient attendances Pregnancy
Secondary Outcome Neonatal and infant mortality rate Delivery
Secondary Outcome Prevalence of congenital malaria Delivery
Secondary Outcome Incidence of malaria during the first year of life Post-Delivery
Secondary Outcome Frequency of drug adverse reactions Pregnancy
Secondary Outcome Frequency of congenital malformations Delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenya medical research institute Kisumu Kenya
Centro de Investigaçao em Saude de Manhiça Manhica Mozambique
Ifakara Health Institute Ifakara Tanzania
Faculté des Sciencies de la Sante Cotonou, Benin Benin
Medical Research Unit Lambarene, Gabon Gabon
FUNDING SOURCES
Name of source Street address City Postal code Country
Malaria in Pregnancy Consortium_LSTM Pembroke Plac e, Liverpool L3 5QA United Kingdom
Malaria in Pregnancy Consortium_LSTM Pembroke Plac e, Liverpool L3 5QA United Kingdom
EDCTP
EDCTP
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FCRB Villaroel 170 Barcelona 08036 Spain Charities/Societies/Foundation
Primary Sponsor FCRB Villaroel 170 Barcelona 08036 Spain Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Institute of Tropical Medicine Wilhelmsrasse 27 Tubingen 72074 Germany
Institute of Tropical Medicine Wilhelmsrasse 27 Tubingen 72074 Germany
MRU, Albert Schweizer Hospital P B 118 Lambaréné PB 118 Gabon
MRU, Albert Schweizer Hospital P B 118 Lambaréné PB 118 Gabon
Ifakara health Institute PB 53 Ikakara Morogoro PO box 53 Tanzania
Ifakara health Institute PB 53 Ikakara Morogoro PO box 53 Tanzania
KEMRI PO box 1578 Kisumu 41100 Kenya
KEMRI PO box 1578 Kisumu 41100 Kenya
VSCR Kolblgasse 10 Vienna 1030 Austria
VSCR Kolblgasse 10 Vienna 1030 Austria
CISM Rua 12 Manhiça 1929 Mozambique
CISM Rua 12 Manhiça 1929 Mozambique
IRD 4 ave de l'Observatoire Paris 75270 France
IRD 4 ave de l'Observatoire Paris 75270 France
FSS, Université Abomey Calavi 08 BP 841 Cotonou 08 BP 841 Benin
FSS, Université Abomey Calavi 08 BP 841 Cotonou 08 BP 841 Benin
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Clara Menedez menendez@clinic.ub.es 34932751851 Rossello 132 , 5th floor
City Postal code Country Position/Affiliation
Barcelona 08036 Spain Head Reproductive and Maternal Health
Role Name Email Phone Street address
Public Enquiries Golbahar Pahlavan pahlavan@clinic.ub.es 34932271851 Rossello 132, 5th floor
City Postal code Country Position/Affiliation
Barcelona 08036 Spain Project manager
Role Name Email Phone Street address
Scientific Enquiries Raquel Gonzalez ragonza@clinic.ub.es 34952271851 Rossello 132, 5th floor
City Postal code Country Position/Affiliation
Barcelona 08036 Spain Research Fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information