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Completed

NCT Number: NCT02769013

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

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

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Key information

Age range

6 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ayôla Akim ADEGNIKA, Lambaréné, Albert Schweitzer Hospital, Gabon

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About this study

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

  • 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.
  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-treatment follow up

Other

No active intervention; medical support provided if needed

S. haematobium treatment

Other

Praziquantel-treatment for S. haematobium positive volunteers

Other names: Praziquantel-treatment

Post treatment follow up

Other

No active intervention; medical support provided if needed.

Olfactometer experiment

Other

No active intervention; medical support provided if needed.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Acronym: TRANSMAL

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
May 11, 2016
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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