Assessing the Effect of Neglected Tropical Diseases on Plasmodium Falciparum Transmission in an Area of Co-endemicity
TRANSMAL
1 other identifier
observational
380
2 countries
2
Brief Summary
Assessing the effect of neglected tropical diseases on Plasmodium falciparum transmission in an area of co endemicity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 21, 2016
CompletedFirst Posted
Study publicly available on registry
May 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedNovember 4, 2020
October 1, 2017
3.5 years
April 21, 2016
November 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with Plasmodium falciparum gametocytes and/or asexual blood stages
Presence of Plasmodium falciparum gametocytes and/or asexual blood stages will be assessed by a quantitative real-time PCR assay in the blood obtained from participants. Unit of measurements for both parameters is numbers/µl.
15 months
Secondary Outcomes (2)
Number of participants with positive serum antibodies specific to the asexual and gametocyte stages of Plasmodium falciparum.
15 months
Percentage of mosquitoes attracted to Schistosoma-infected participants to non-infected individuals in a wind-tunnel assay.
15 months
Other Outcomes (1)
Proportion of Plasmodium infected Anopheles mosquitoes per individual per night
3 months
Study Arms (4)
S. haematobium positives in Gabon
Asymptomatic volunteers infected with S. haematobium and living in Gabon
S. haematobium negatives in Gabon
Volunteers not infected with S. haematobium and living in Gabon
S. haematobium positives in Ghana
Asymptomatic volunteers infected with S. haematobium and living in Ghana
S. haematobium negatives in Ghana
Volunteers not infected with S. haematobium and living in Ghana
Interventions
No active intervention; medical support provided if needed
Praziquantel-treatment for S. haematobium positive volunteers
No active intervention; medical support provided if needed.
No active intervention; medical support provided if needed.
Eligibility Criteria
The study population are subjects aged from 6 to 30 years since both adults and children have been shown to be a reservoir of P. falciparum. Participants will be recruited in two African villages located in Gabon (lambarene) and Ghana Asokwa submetropolitan area in Kumasi, Ghana. Settings in the two locations are different and represent a rural area with very high infectious pressure from helminths infection (S. haematobium and geohelminths) as well as year-round transmission of malaria in the Central African rain forest (Lambaréné) and a more densely populated area in West Africa with pronounced seasonal variation in malaria transmission and high endemicity of S. haematobium but very little other helminthiases due to well-implemented mass treatment campaigns.
You may qualify if:
- Subjects aged from 6 to 30 years
- Without severe or moderate disease
- Agreement to be enrolled in the study (written informed consent or consent by the legal representative and assent)
- Living in the study area for at least 1 year
You may not qualify if:
- Anaemia with haemoglobin less than 8g/dl
- Know sickle cell disease
- Macroscopic haematuria
- Any other know severe disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ayôla Akim ADEGNIKA
Lambaréné, Albert Schweitzer Hospital, 118, Gabon
KCCR
Kumasi, Ghana
Related Publications (2)
Edoa JR, Adegbite BR, Honkpehedji YJ, Zinsou JF, Boussougou-Sambe ST, Woldearegai TG, Mordmuller B, Adegnika AA, Dejon-Agobe JC. Epidemiology of soil-transmitted helminth infections and the differential effect of treatment on the distribution of helminth species in rural areas of Gabon. Trop Med Health. 2024 Jan 2;52(1):3. doi: 10.1186/s41182-023-00567-z.
PMID: 38163912DERIVEDDejon-Agobe JC, Edoa JR, Honkpehedji YJ, Zinsou JF, Adegbite BR, Ngwese MM, Mangaboula A, Lell B, Woldearegai TG, Grobusch MP, Mordmuller B, Adegnika AA. Schistosoma haematobium infection morbidity, praziquantel effectiveness and reinfection rate among children and young adults in Gabon. Parasit Vectors. 2019 Dec 10;12(1):577. doi: 10.1186/s13071-019-3836-6.
PMID: 31823806DERIVED
Biospecimen
Blood sample and urine collection potentially containing genetic material of Plasmodium falciparum and Schistosoma haematobium
Study Officials
- PRINCIPAL INVESTIGATOR
Ulysse ATEBA NGOA, Dr.
CERMEL, Lambarene, GABON
- PRINCIPAL INVESTIGATOR
Oumou MAIGA, PhD
KCCR, Kumasi, Ghana
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2016
First Posted
May 11, 2016
Study Start
April 1, 2016
Primary Completion
October 1, 2019
Study Completion
October 1, 2020
Last Updated
November 4, 2020
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share