Sustaining the control of intestinal schistosomiasis mansoni in Western Kenya
| ISRCTN | ISRCTN14849830 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14849830 |
| Secondary identifying numbers | Sm1 4787606 |
- Submission date
- 17/11/2015
- Registration date
- 18/11/2015
- Last edited
- 24/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Schistosomiasis is a chronic (long term) infection caused by parasites that live in fresh water (for example, rivers and lakes) in tropical and subtropical countries. Symptoms of the disease vary widely and can be fairly mild (fever, skin rash, coughing) or more serious (passing blood in diarrhoea or urine, vomiting blood, stomach pains, paralysis of the legs). Over 90% of cases occur in Africa. The World Health Organisation wants to treat 75% of the population at risk of schistosomiasis infection by 2020 and preventive treatment (chemotherapy) will increase massively as a result. In Kenya, where both S. mansoni and S. haematobium are endemic and many people suffer from intestinal or urogenital schistosomiasis (schistosomiasis affecting the urinary and genital organs) no large-scale preventive chemotherapy programme had been set up before the start of this study. We want to investigate which combination of annual praziquantel treatments (given in schools or in communities) and 'drug holidays' (when no treatment is given) is the most successful for the lowest cost.
Who can participate?
Schoolchildren aged 9-12 years attending one of 75 schools in western Kenya recruited for the study.
This 5-year intervention trial takes place in 75 schools in western Kenya.
What does the study involve?
In a first step, in-depth parasitological surveys are carried out in each participating school where the number of children infected with S. mansoni (prevalence) ranges between 10% and 24%. Prevalence is measured using Kato-Katz thick smears (a laboratory technique for looking for parasite eggs in stool samples) from 50 children aged 13-14 years per locality (or region). Each school is then randomly allocated into one of three groups. Schoolchildren attending schools in group 1 are treated with praziquantel once a year for the 5 years of the study. Schoolchildren attending schools in group 2 are treated for the first two years of the study. Children attending schools in group 3 are treated in the first year and the third year of the study. Three days of consecutive parasitological surveys are carried out before each treatment to assess any changes to the prevalence and intensity (severity of infection) of S. mansoni infection over time. The praziquantel is administered by trained teachers to all children aged 5-15 years.
What are the possible benefits and risks of participating?
Disease due to schistosomiasis will be reduced among children who receive treatment of praziquantel. Praziquantel is generally well tolerated, if not taken on empty stomach. Side effects are typically mild and temporary and do not require treatment. They include malaise (feeling out of sorts), headache, dizziness, abdominal discomfort (with or without nausea), high temperature and, rarely, urticarial (hives). Children will remain under medical supervision after treatment and appropriate measures will be taken if need be.
Where is the study run from?
Kenya Medical Institute for Research
When is the study starting and how long is it expected to run for
January 2010 to December 2016
Who is funding the study?
The Bill & Melinda Gates Foundation (USA)
Who is the main contact?
Dr Diana Karanja
diana@cohesu.com
Contact information
Public
Kenya Medical Research Institute
PO Box 1578
Kisumu
40100
Kenya
| Phone | 254-72-215-4838 |
|---|---|
| diana@cohesu.com |
Study information
| Study design | Randomised intervention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | School |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Comparison of school-based mass drug administration delivery strategies for control of Schistosoma mansoni infections in Western Kenya |
| Study hypothesis | The implementation of two rounds of preventive chemotherapy with the antischistosomal drug praziquantel to school-aged children (exclusion of children <5 years) over a 4-year period (either alternating with drug holidays in years 2 and 4, or drug holidays in years 3 and 4) will more cost-effectively sustain the control of morbidity due to Schistosoma mansoni infection in areas with moderate endemicity (prevalence: 10-24%) in Kenya than the implementation of four rounds of annual chemotherapy. |
| Ethics approval(s) | Kenya Medical Research Institute, 25/08/2010, ref: KEMRI/RES/7/3/1 |
| Condition | Schistosomiasis |
| Intervention | In a first step, in-depth parasitological surveys are carried out in 75 schools where the prevalence of S. mansoni (i.e. number of infections) amongst schoolchildren ranges between 10% and 24%. Prevalence is measured using Kato-Katz thick smears from 50 children aged 13-14 years per locality. Each school is then randomly allocated into one of three groups. Schoolchildren attending schools in group 1 are treated with praziquantel once a year for the 5 years of the study. Schoolchildren attending schools in group 2 are treated for the first two years of the study. Children attending schools in group 3 are treated in the first year and the third year of the study. Three days of consecutive parasitological surveys are carried out before each treatment to assess any changes to the prevalence and intensity (severity of infection) of S. mansoni infection over time. The praziquantel is administered by trained teachers to all children aged 5-15 years. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Praziquantel |
| Primary outcome measure | Identification of the most cost-effective strategy that is able to reduce S. mansoni infection from moderate (10-24%) to low prevalence levels (<10%). Measured by change in prevalence and intensity of Schistosoma mansoni infection in cohorts of 9- to 12-year-old children over the four years of intervention. |
| Secondary outcome measures | 1. Prevalence and intensity of S. mansoni infections in 9- to-12- year-old schoolchildren, using Kato-Katz thick smears 2. Prevalence and intensity of S. mansoni infections in first-year schoolchildren, using Kato-Katz thick smears 3. Control of morbidity due to S. mansoni (reduction of the prevalence to <10%) in the 75 schools 4. Identification of S. mansoni risk factors 5. Mapping and prediction of the distribution S. mansoni in Western Kenya Measured by changes in force of transmission, as assessed by infection prevalence and intensity of S. mansoni in first-year students and adults. |
| Overall study start date | 12/01/2010 |
| Overall study end date | 31/12/2016 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 40,000 |
| Participant inclusion criteria | 1. Schoolchildren, either male or female, aged 9-12 years, attending the selected schools (in each study year) 2. First-year students, either male or female, attending the selected schools (in years 1 and 5) 3. Written informed consent signed by parents or legal guardians of the schoolchildren 4. Oral assent from schoolchildren 5. At least one stool sample provided over three consecutive days from 9- to 12- years- old children each study year 6. At least one stool sample provided from first-year students in years 1 and 5 |
| Participant exclusion criteria | 1. Children not aged 9-12 years (in years 2, 3 and 4) 2. Children not aged 9-12 years or being first-year students (in years 1 and 5) 3. No written informed consent by parents or legal guardians of schoolchildren 4. No oral assent given by schoolchildren 5. No stool sample provided (for 9- to 12-year-old children in each study year; for first-year students in years 1 and 5) |
| Recruitment start date | 01/12/2010 |
| Recruitment end date | 31/12/2016 |
Locations
Countries of recruitment
- Kenya
Study participating centre
Kisumu
40100
Kenya
Sponsor information
University/education
145 Coverdell Center
500 DW Brooks Drive
Athens, Georgia
30602
United States of America
| Phone | 706-542-1879 |
|---|---|
| ccamp@uga.edu | |
"ROR" |
https://ror.org/00te3t702 |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/03/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol and baseline data | 26/05/2016 | Yes | No | |
| Results article | results | 23/10/2017 | Yes | No |
Editorial Notes
24/10/2017: Publication reference added.
31/05/2016: Publication reference added.
