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.: PACTR201211000449232 Date of Approval:
Trial Status:
TRIAL DESCRIPTION
Public title Intermittent Preventive Treatment: efficacy and safety of sulfadoxine-pyrimethamine and sulfadoxine-pyrimethamine plus piperaquine in schoolchildren.
Official scientific title Intermittent Preventive Treatment: efficacy and safety of sulfadoxine-pyrimethamine and sulfadoxine-pyrimethamine plus piperaquine in schoolchildren of the Democratic Republic of Congo. A Randomised Control Trial.
Brief summary describing the background and objectives of the trial This study is a phase IIIb, open label, randomised controlled trial to investigate the efficacy and safety of antimalaria intermittent preventive treament. Asymptomatic schoolchildren will be enroled. There will be one arm for sulfadoxine-pyrimethamine, one for sulfadoxine-pyrimethamine plus piperaquine, and one control arm. The treatments will be given at baseline, month 4, and month 8 of follow-up. Each treatment arm will be compared to a control group and followed-up for 12 months.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PIP IPT
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 15/09/2012
Actual trial start date 12/11/2012
Anticipated date of last follow up 15/09/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 1100
Actual target sample size (number of participants) 1100
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ESP/CE/045/2012 Comité Ethique, Ecole de Santé Publique, République Démocratique Du Congo.
B300201214729 Ethical Committee of the University of Antwerp, Belgium
NCT01722539 Clin Trial Gov
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 Permuted block randomisation (block of three with variable block size) using a randomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SP a single dose of ½ tablets of sulfadoxine 500 mg - pyrimethamine 25 mg per 10 kg Every 4 months for a follow-up of 12 months Sulfadoxin plus pyrimethamine 367
Experimental Group SP-PQ single dose of ½ tablets of sulfadoxine 500 mg - pyrimethamine 25 mg per 10 kg associated with two doses of 16 mg/kg of piperaquine phosphate given in 24 hours interval. Every 4 months for a follow-up of 12 months Loose combination therapy 367
Control Group Control group 366 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- males and females primary school children, anticipated local residence for the study duration, signed or thumb-printed informed consent by the parents or guardians and witnessed by an impartial witness (whenever parents/guardians are illiterate) informed ascent for 12-year children or more Children of the 6th primary school year Participation in any other investigational drug study (antimalarial or others) during the previous 30 days. Known hypersensitivity or serious adverse events (AE) to study drugs. Clinical malaria at baseline irrespectively of the severity (World Health Organisation malaria treatment guideline 2010) (Annex III). Febrile conditions caused by diseases other than malaria at first visit. Clinical symptoms of severe anaemia Illness or conditions like hematologic, cardiac, renal, hepatic diseases which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency and sickle cell. Body weight < 14 Kg Children with major chronic infectious diseases. 5 Year(s) 15 Year(s) Both
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 25/10/2012 University Antwerp Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Wilrijkstraat 10 Edegem 2650 Belgium
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 12/07/2012 Comité Ethique de l'Ecole de Santé Publique
Ethics Committee Address
Street address City Postal code Country
Université de kinshasa, Faculté de Medecine Kinshasa 11850 Kin I Democratic Republic of the Congo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hemoglobin concentration Month 0 Month 4 Month 8 Month 12
Secondary Outcome malaria incidence Month 4 Month 8 Month 12
Secondary Outcome Malaria prevalence Baseline Month 12
Secondary Outcome Prevalence of P. falciparum dihydrofolate reductase and dihydropteroate synthase markers Month 0 Month 12
Secondary Outcome malaria parasitemia Month 0 Month 4 Month 8 Month 12
Secondary Outcome Rate of malnutrition Month 0 Month 4 Month 8 Month 12
Secondary Outcome Educational performance Month 0 Month 12
Secondary Outcome School attendance Month 0 Month 12
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ecole Publique Biyombi-Likabo Avenue du marché Kimbanséké-Mukali 46 Democratic Republic of the Congo
FUNDING SOURCES
Name of source Street address City Postal code Country
Fonds Wetenschappelijk Onderzoek Edmonstraat 5 Brussels 1000 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Antwerp Universiteitplein 1 Antwerp (Wilrijk) 2610 Belgium University
COLLABORATORS
Name Street address City Postal code Country
Université de Kinshasa, Faculté de médecine B.P. 747 Kinshasa XI Kinshasa Faculté de médecine Democratic Republic of the Congo
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jean-Pierre Van geertruyden Jean-Pierre.VanGeertruyden@ua.ac.be ++ 32 326 525 28 Universiteitplein
City Postal code Country Position/Affiliation
Wilrijk-Antwerp 2610 Belgium International Health Unit, University of Antwerp
Role Name Email Phone Street address
Public Enquiries JP Van geertruyden jean-pierre.vangertruyden@uantwerpen.uantwerpen.be 003232652528 Universiteitplein
City Postal code Country Position/Affiliation
Antwerp-Wilrijk 2610 Belgium International Health Unit, University of Antwerp
Role Name Email Phone Street address
Scientific Enquiries JP Van geertruyden jean-pierre.vangeertruyden@uantwerpen.be 003232652528 Universiteitplein
City Postal code Country Position/Affiliation
Wilrijk-Antwerp 2610 Belgium International Health Unit, University of Antwerp
REPORTING
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