Assessing the Effect of Neglected Tropical Diseases on Plasmodium Falciparum Transmission in an Area of Co-endemicity (TRANSMAL)

November 3, 2020 updated by: University Hospital Tuebingen
Assessing the effect of neglected tropical diseases on Plasmodium falciparum transmission in an area of co endemicity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The project is divided in three different work packages that cover the life cycle of P. falciparum :

  1. In Work Package 1 (WP1) the investigators will assess whether S. haematobium infection increases the human reservoir of P. falciparum by increasing the carriage rate and incidence of P. falciparum gametocytaemia as well as by increasing the proportion and incidence of subject with sub-microscopic P. falciparum infection. The investigators will also determine whether this increase in gametocyte carriage is a consequence of an impairment of the immune response of helminth infected subjects to P. falciparum.
  2. In Work Package 2 (WP2) the investigators will determine whether the transmission of the sexual forms of P. falciparum from the human host to mosquito is increased in S. haematobium infected subjects compared to uninfected controls. Moreover the investigators will study whether the immunological changes induced in S. haematobium infected subjects lead to a decrease of the transmission reducing activity of IgG specific to Pfs48/45 and Pfs230 (both capable of blocking/impairing further development of P. falciparum in the mosquito gut).
  3. Finally in Work Package 3 (WP3) the investigators will assess whether S. haematobium infection affects the transmission of P. falciparum from the mosquito to the human host. This effect will be determined indirectly by assessing whether S. haematobium infected subjects are more attractive to mosquitoes.

Study Type

Observational

Enrollment (Actual)

380

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Gabon
    • Albert Schweitzer Hospital
      • Lambarene, Albert Schweitzer Hospital, Gabon, 118
        • Ayôla Akim ADEGNIKA
  • Ghana
      • Kumasi, Ghana
        • KCCR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 30 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Anaemia with haemoglobin less than 8g/dl
  • Know sickle cell disease
  • Macroscopic haematuria
  • Any other know severe disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
S. haematobium positives in Gabon
Asymptomatic volunteers infected with S. haematobium and living in Gabon
Other: Pre-treatment follow up
No active intervention; medical support provided if needed
Other: S. haematobium treatment
Praziquantel-treatment for S. haematobium positive volunteers
Other Names:
  • Praziquantel-treatment
Other: Post treatment follow up
No active intervention; medical support provided if needed.
Other: Olfactometer experiment
No active intervention; medical support provided if needed.
S. haematobium negatives in Gabon
Volunteers not infected with S. haematobium and living in Gabon
Other: Pre-treatment follow up
No active intervention; medical support provided if needed
Other: Post treatment follow up
No active intervention; medical support provided if needed.
Other: Olfactometer experiment
No active intervention; medical support provided if needed.
S. haematobium positives in Ghana
Asymptomatic volunteers infected with S. haematobium and living in Ghana
Other: Pre-treatment follow up
No active intervention; medical support provided if needed
Other: S. haematobium treatment
Praziquantel-treatment for S. haematobium positive volunteers
Other Names:
  • Praziquantel-treatment
Other: Post treatment follow up
No active intervention; medical support provided if needed.
Other: Olfactometer experiment
No active intervention; medical support provided if needed.
S. haematobium negatives in Ghana
Volunteers not infected with S. haematobium and living in Ghana
Other: Pre-treatment follow up
No active intervention; medical support provided if needed
Other: Post treatment follow up
No active intervention; medical support provided if needed.
Other: Olfactometer experiment
No active intervention; medical support provided if needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Plasmodium falciparum gametocytes and/or asexual blood stages
Time Frame: 15 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with positive serum antibodies specific to the asexual and gametocyte stages of Plasmodium falciparum.
Time Frame: 15 months
Number of participants with serum antibodies against P. falciparum gametocyte and/or asexual blood stage antigens will be assessed.
15 months
Percentage of mosquitoes attracted to Schistosoma-infected participants to non-infected individuals in a wind-tunnel assay.
Time Frame: 15 months
100 mosquitoes will be released to Schistosoma infected and non-infected participants simultaneously lying in different tents in a two-way olfactometer.
15 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Plasmodium infected Anopheles mosquitoes per individual per night
Time Frame: 3 months
Mosquitoes will be collected by Human Landing catches and species of mosquitoes and presence of Plasmodium falciparum will be determined by morphology and PCR.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Ulysse ATEBA NGOA, Dr., CERMEL, Lambarene, GABON
  • Principal Investigator: Oumou MAIGA, PhD, KCCR, Kumasi, Ghana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ACTUAL)

October 1, 2019

Study Completion (ACTUAL)

October 1, 2020

Study Registration Dates

First Submitted

April 21, 2016

First Submitted That Met QC Criteria

May 9, 2016

First Posted (ESTIMATE)

May 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Transmal study version 2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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