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

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ClinicalTrials.gov Identifier: NCT02769013
Recruitment Status : Recruiting
First Posted : May 11, 2016
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

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

Condition or disease Intervention/treatment
Malaria Transmission Other: Pre-treatment follow up Other: S. haematobium treatment Other: Post treatment follow up Other: Olfactometer experiment

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.

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Study Type : Observational
Estimated Enrollment : 395 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessing the Effect of Neglected Tropical Diseases on Plasmodium Falciparum Transmission in an Area of Co-endemicity
Study Start Date : April 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood sample and urine collection potentially containing genetic material of Plasmodium falciparum and Schistosoma haematobium


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769013


Contacts
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Contact: Benjamin MORDMÜLLER, PD.Dr 0049707129 ext 85446 benjamin.mordmueller@uni-tuebingen.de
Contact: Ayôla Akim ADEGNIKA, Dr 0024107989191 aadegnika@gmail.com

Locations
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Gabon
Ayôla Akim ADEGNIKA Recruiting
Lambarene, Albert Schweitzer Hospital, Gabon, 118
Contact: Ayôla Akim ADEGNIKA, Dr    0024107989191    aadegnika@gmail.com   
Contact: Ulysse ATEBA NGOA, Dr    0024107989191    ulyssus7000@gmail.com   
Principal Investigator: Ulysse ATEBE NGOA, Dr         
Sub-Investigator: Ronald EDOA, Dr         
Sub-Investigator: Jean Claude DEJON, Dr         
Ghana
KCCR Not yet recruiting
Kumasi, Ghana
Contact: Ellis OWUSU-DABO, Dr    002333220 ext 60451    owusudabo@kccr.de   
Contact: Oumou MAIGA, PhD    002333220 ext 60451    maiga@bni-hamburg.de   
Principal Investigator: Oumou MAIGA, Dr         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Ulysse ATEBA NGOA, Dr. CERMEL, Lambarene, GABON
Principal Investigator: Oumou MAIGA, PhD KCCR, Kumasi, Ghana

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02769013     History of Changes
Other Study ID Numbers: Transmal study version 2.0
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital Tuebingen:
Schistosoma haematobium plasmodium falciparum transmission
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Praziquantel
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents