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CompletedNCT02769013TRANSMALUpdated Nov 4, 2020

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

An observational study in Malaria Transmission, sponsored by University Hospital Tuebingen. Completed at 2 sites in 2 countries. Open to participants aged 6 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-04.

Sponsored by University Hospital Tuebingen · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
380
Ages
6 Years to 30 Years
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Malaria Transmission

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Keywords

  • Schistosoma haematobium plasmodium falciparum transmission
03

In context

Malaria

1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.

This study's enrollment of 380 is below the median of 582 across 204 observational studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 30 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects aged from 6 to 30 years
  • Without severe or moderate disease
  • Agreement to be enrolled in the study (written or consent by the legal representative and assent)
  • Living in the study area for at least 1 year

Exclusion criteria

Exclusion Criteria:

  • Anaemia with less than 8g/dl
  • Know sickle cell disease
  • Macroscopic haematuria
  • Any other know severe disease
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
380 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • S. haematobium positives in Gabon

    Asymptomatic volunteers infected with S. haematobium and living in Gabon

    Other: Pre-treatment follow up · Other: S. haematobium treatment · Other: Post treatment follow up · Other: Olfactometer experiment

  • S. haematobium negatives in Gabon

    Volunteers not infected with S. haematobium and living in Gabon

    Other: Pre-treatment follow up · Other: Post treatment follow up · Other: Olfactometer experiment

  • S. haematobium positives in Ghana

    Asymptomatic volunteers infected with S. haematobium and living in Ghana

    Other: Pre-treatment follow up · Other: S. haematobium treatment · Other: Post treatment follow up · Other: Olfactometer experiment

  • S. haematobium negatives in Ghana

    Volunteers not infected with S. haematobium and living in Ghana

    Other: Pre-treatment follow up · Other: Post treatment follow up · Other: Olfactometer experiment

Interventions

  • OtherPre-treatment follow up

    No active intervention; medical support provided if needed

  • OtherS. haematobium treatment

    Praziquantel-treatment for S. haematobium positive volunteers

    Also known as: Praziquantel-treatment

  • OtherPost treatment follow up

    No active intervention; medical support provided if needed.

  • OtherOlfactometer experiment

    No active intervention; medical support provided if needed.

06

What researchers measure

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.

    Time frame: 15 months

Secondary outcomes

  1. Number of participants with positive serum antibodies specific to the asexual and gametocyte stages of Plasmodium falciparum.

    Number of participants with serum antibodies against P. falciparum gametocyte and/or asexual blood stage antigens will be assessed.

    Time frame: 15 months

  2. Percentage of mosquitoes attracted to Schistosoma-infected participants to non-infected individuals in a wind-tunnel assay.

    100 mosquitoes will be released to Schistosoma infected and non-infected participants simultaneously lying in different tents in a two-way olfactometer.

    Time frame: 15 months

Other outcomes

  1. Proportion of Plasmodium infected Anopheles mosquitoes per individual per night

    Mosquitoes will be collected by Human Landing catches and species of mosquitoes and presence of Plasmodium falciparum will be determined by morphology and PCR.

    Time frame: 3 months

07

Study locations

2 sites
  • Ayôla Akim ADEGNIKA
    Lambarene, Albert Schweitzer Hospital 118, Gabon
  • KCCR
    Kumasi, Ghana
08

References and documents

Publications

  • 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. Erratum In: Parasit Vectors. 2021 Jun 21;14(1):329. doi: 10.1186/s13071-021-04815-1. PubMed 31823806 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2016, a primary completion of Oct 2019 and a completion of Oct 2020. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2016
First posted
May 11, 2016
Start
Apr 2016
Primary completionActual
Oct 2019
CompletionActual
Oct 2020
Last update
Nov 4, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02769013
Responsible party
Sponsor
First posted
May 11, 2016
Start date
Apr 2016
Primary completion
Oct 2019
Completion
Oct 2020
Last update
Nov 4, 2020

Study contacts

Ulysse ATEBA NGOA, Dr.
principal investigator · CERMEL, Lambarene, GABON
Oumou MAIGA, PhD
principal investigator · KCCR, Kumasi, Ghana

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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