Malaria TransmissionTRANSMALNCT02769013
Assessing the Effect of Neglected Tropical Diseases on Plasmodium Falciparum Transmission in an Area of Co-endemicity
An observational study of Malaria Transmission, run by University Hospital Tuebingen at 2 sites in 2 countries.
Trial summary
Assessing the effect of neglected tropical diseases on Plasmodium falciparum transmission in an area of co endemicity. Read more about this study
- Who is it for?
- Ages 6 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria Transmission
- What is being tested?
- Pre-treatment follow up, S. haematobium treatment and Post treatment follow up
- How many people
- 380 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2016to Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Anaemia with haemoglobin less than 8g/dl
- Know sickle cell disease
- Macroscopic haematuria
- Any other know severe disease
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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 :
- 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.
- Conditions
- Malaria Transmission
- Being tested
- Pre-treatment follow up, S. haematobium treatment, Post treatment follow up, Olfactometer experiment
- Keywords
- Schistosoma haematobium plasmodium falciparum transmission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-treatment follow upOther
No active intervention; medical support provided if needed
S. haematobium treatmentOther
Also called Praziquantel-treatment
Praziquantel-treatment for S. haematobium positive volunteers
Post treatment follow upOther
No active intervention; medical support provided if needed.
Olfactometer experimentOther
No active intervention; medical support provided if needed.
| Study group | Role | What they receive |
|---|---|---|
| S. haematobium positives in Gabon | Asymptomatic volunteers infected with S. haematobium and living in Gabon Receives: 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 Receives: 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 Receives: 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 Receives: Other: Pre-treatment follow up; Other: Post treatment follow up; Other: Olfactometer experiment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months
Secondary outcomes (2)
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.
Measured: 15 months
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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2019
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malaria TransmissionStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulysse ATEBA NGOA, Dr., Principal investigator, CERMEL, Lambarene, GABONOumou MAIGA, PhD, Principal investigator, KCCR, Kumasi, Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769013
- Sponsor's protocol ID
- Transmal study version 2.0
- Acronym
- TRANSMAL
- Status last verified
- Oct 2017
- First submitted
- 21 Apr 2016
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38163912Dejon-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.
PubMed 31823806
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Neglected Tropical Diseases on Plasmodium Falciparum Transmission in an Area of Co-endemicity
- ClinicalTrials.gov ID
- NCT02769013
- Acronym / sponsor ID
- TRANSMAL / Transmal study version 2.0
- Conditions
- Malaria Transmission
- Keywords
- Schistosoma haematobium plasmodium falciparum transmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessing the effect of neglected tropical diseases on Plasmodium falciparum transmission in an area of co endemicity.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| S. haematobium positives in Gabon | – | Other: Pre-treatment follow up, Other: S. haematobium treatment, Other: Post treatment follow up, Other: Olfactometer experimentAsymptomatic volunteers infected with S. haematobium and living in Gabon |
| S. haematobium negatives in Gabon | – | Other: Pre-treatment follow up, Other: Post treatment follow up, Other: Olfactometer experimentVolunteers not infected with S. haematobium and living in Gabon |
| S. haematobium positives in Ghana | – | Other: Pre-treatment follow up, Other: S. haematobium treatment, Other: Post treatment follow up, Other: Olfactometer experimentAsymptomatic volunteers infected with S. haematobium and living in Ghana |
| S. haematobium negatives in Ghana | – | Other: Pre-treatment follow up, Other: Post treatment follow up, Other: Olfactometer experimentVolunteers not infected with S. haematobium and living in Ghana |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Anaemia with haemoglobin less than 8g/dl
- Know sickle cell disease
- Macroscopic haematuria
- Any other know severe disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-treatment follow upNo active intervention; medical support provided if needed | Other | S. haematobium negatives in Gabon, S. haematobium negatives in Ghana, S. haematobium positives in Gabon, S. haematobium positives in Ghana |
| S. haematobium treatmentAlso: Praziquantel-treatmentPraziquantel-treatment for S. haematobium positive volunteers | Other | S. haematobium positives in Gabon, S. haematobium positives in Ghana |
| Post treatment follow upNo active intervention; medical support provided if needed. | Other | S. haematobium negatives in Gabon, S. haematobium negatives in Ghana, S. haematobium positives in Gabon, S. haematobium positives in Ghana |
| Olfactometer experimentNo active intervention; medical support provided if needed. | Other | S. haematobium negatives in Gabon, S. haematobium negatives in Ghana, S. haematobium positives in Gabon, S. haematobium positives in Ghana |
Primary outcome
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.
2 secondary outcomes
Number of participants with positive serum antibodies specific to the asexual and gametocyte stages of Plasmodium falciparum.
Time frame: 15 months
Percentage of mosquitoes attracted to Schistosoma-infected participants to non-infected individuals in a wind-tunnel assay.
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 38163912Edoa 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.
- Derived from this study: PubMed 31823806Dejon-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulysse ATEBA NGOA, Dr. principal investigator
CERMEL, Lambarene, GABON
Oumou MAIGA, PhD principal investigator
KCCR, Kumasi, Ghana
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria Transmission, run by University Hospital Tuebingen at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Gabon, Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Plasmodium falciparum gametocytes and/or asexual blood stages (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02769013, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.