NCT02769013

Brief Summary

Assessing the effect of neglected tropical diseases on Plasmodium falciparum transmission in an area of co endemicity.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 4, 2020

Status Verified

October 1, 2017

Enrollment Period

3.5 years

First QC Date

April 21, 2016

Last Update Submit

November 3, 2020

Conditions

Keywords

Schistosoma haematobium plasmodium falciparum transmission

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

Other: Pre-treatment follow upOther: S. haematobium treatmentOther: Post treatment follow upOther: Olfactometer experiment

S. haematobium negatives in Gabon

Volunteers not infected with S. haematobium and living in Gabon

Other: Pre-treatment follow upOther: Post treatment follow upOther: Olfactometer experiment

S. haematobium positives in Ghana

Asymptomatic volunteers infected with S. haematobium and living in Ghana

Other: Pre-treatment follow upOther: S. haematobium treatmentOther: Post treatment follow upOther: Olfactometer experiment

S. haematobium negatives in Ghana

Volunteers not infected with S. haematobium and living in Ghana

Other: Pre-treatment follow upOther: Post treatment follow upOther: Olfactometer experiment

Interventions

No active intervention; medical support provided if needed

S. haematobium negatives in GabonS. haematobium negatives in GhanaS. haematobium positives in GabonS. haematobium positives in Ghana

Praziquantel-treatment for S. haematobium positive volunteers

Also known as: Praziquantel-treatment
S. haematobium positives in GabonS. haematobium positives in Ghana

No active intervention; medical support provided if needed.

S. haematobium negatives in GabonS. haematobium negatives in GhanaS. haematobium positives in GabonS. haematobium positives in Ghana

No active intervention; medical support provided if needed.

S. haematobium negatives in GabonS. haematobium negatives in GhanaS. haematobium positives in GabonS. haematobium positives in Ghana

Eligibility Criteria

Age6 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

Location

KCCR

Kumasi, Ghana

Location

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.

  • Dejon-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.

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample and urine collection potentially containing genetic material of Plasmodium falciparum and Schistosoma haematobium

Study Officials

  • Ulysse ATEBA NGOA, Dr.

    CERMEL, Lambarene, GABON

    PRINCIPAL INVESTIGATOR
  • Oumou MAIGA, PhD

    KCCR, Kumasi, Ghana

    PRINCIPAL INVESTIGATOR

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

Locations