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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201601001416338 Date of Registration: 09/01/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Praziquantel efficacy
Official scientific title Efficacy of single vs. multiple Praziquantel MDA against Schistosoma mansoni infections among primary school children
Brief summary describing the background and objectives of the trial Globally about 207 million people are infected with Schistosomes and more than 700 million are at risk of infection, 93% of which occurs in SSA, and Tanzania ranks second to Nigeria for having the highest burden of Schistosomiasis in the region. Schistosomiasis has been controlled using snail control, chemotherapy, health education, and improved sanitation. WHO recommends regular treatment with Praziquantel of all school-aged children at risk of Schistosomiasis in order to control morbidity associated with the disease. It is anticipated that the use of Praziquantel will increase in the years to come, this intensified treatment posses a selection pressure to the Schistosome, posing a threat of developing resistance to praziquantel. Reduced sensitivity of Schistosoma mansoni to Praziquantel has been reported elsewhere and in Tanzania, a study done in Mara region showed that even a single Praziquantel treatment produced a genetic bottleneck with reduction in genetic diversity of Schistosoma mansoni. Since no real alternative drug against schistosomiasis is currently available, WHO recommends to regularly monitor the efficacy of praziquantel and investigate alternative treatment strategies as a means to prolong the usefulness of the drug.The objective of this study is therefore to compare the efficacy of single vs double praziquantel treatments against S.mansoni in terms of egg reduction rates, cure rates and morbidity reduction among primary school children in the study area.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Paediatrics,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 28/09/2015
Actual trial start date 28/09/2015
Anticipated date of last follow up 28/09/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 513
Actual target sample size (number of participants) 513
Recruitment status Closed to recruitment,follow-up continuing
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 Random allocation was achieved by using random numbers generated by SPSS software Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Random allocation was achieved by using random numbers generated by SPSS software Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Praziquantel 40 mg/kg Once This group was given a standard single dose of praziquantel which is currently used in Schistosomiasis control program 215 Dose Comparison
Experimental Group Praziquantel double treatment 40 mg/kg Two times 3 weeks apart This group was given two praziquantel doses 3 weeks apart 216 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
School children between 6 - 19 years of age Children agree to participate in the study Parents give a written informed consent History of being clinically ill and used drug within a period of two weeks before the study Refusal of parents to sign a written informed consent Evidence of being sick during the time of recruitment 6 Year(s) 16 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 22/07/2015 Tanzania National Institute for Medical research
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama drive Dar-es-salaam +255 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Egg reduction rate (ERR) 8 weeks from baseline
Primary Outcome Cure rate (CR) 8 weeks from baseline
Secondary Outcome Regression of morbidities 6 Moths from baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kibuyi Primary School Kibuyi Rorya district, Mara region P.O.Box 250, Rorya United Republic of Tanzania
Busanga Primary School Busanga Rorya district, Mara region P.O.Box 250, Rorya United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
The government of the United republic of Tanzania, through Nelson Mandela African Institution of science and Technology-Arusha Nambala Arusha +255 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nelson Mandela African Institution of science and Technology-Arusha Nambala Arusha +255 United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
Prof. Joram Buza Nambala Arusha P.O.Boc 447, Arusha United Republic of Tanzania
Dr. Safari Kinung'hi National Institute for Medical Research (NIMR), Mwanza Centre, Mwanza United Republic of Tanzania
Dr. Emanuel Mpolya Nambala Arusha P.O.Boc 447, Arusha United Republic of Tanzania
Prof. Don- Jin Kim Nambala Arusha P.O.Boc 447, Arusha United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator David Munisi munisid@nm-aist.ac.tz +255713668857 Nambala
City Postal code Country Position/Affiliation
Arusha P.O.Box 447 United Republic of Tanzania Student
Role Name Email Phone Street address
Public Enquiries Joram Buza buza@nm-aist.ac.tz +255767012616 Nambala
City Postal code Country Position/Affiliation
Arusha P.O.Box 447, Arusha United Republic of Tanzania Supervisor
Role Name Email Phone Street address
Scientific Enquiries Safari Kinung'hi kinunghi_csm@hotmail.com +255784318096 NIMR-Mwanza Centre
City Postal code Country Position/Affiliation
Mwanza United Republic of Tanzania Supervisor
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information