Sleeping SicknessNCT05645822
Screen and Treat Implementation for HAT Control
An observational study of Sleeping Sickness and Trypanosomiasis, African, run by Institute of Tropical Medicine, Belgium.
Trial summary
Human African Trypanosomiasis (HAT), or sleeping sickness, is one of the parasitic diseases targeted for interruption of transmission by 2030 by the WHO. The development of fexinidazole as treatment is a huge step towards this achievement; however, the diagnostic algorithm remains complex due to limited sensitivity… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Sleeping Sickness, Trypanosomiasis, African
- What is being tested?
- Screen&treat
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 30 Jan 2024
- How long will I take part?
- 6 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 9 health facilities in the endemic health zones of Kasongo, Kikombo, Kunda and Samba in the province of Maniema, Kongolo in the province of Tanganyika and Lubao in the province of Lomami are selected based on reported HAT cases 3 years prior, where fexinidazole treatment has been provided through PNLTHA or DNDi and where sample transport will be ensured by the NGO SANRU, despite difficult accessibility. The study aims to include every person that attends the participating fixed healthcare facilitie with suggestive symptoms of gHAT (see above) and is willing to provide informed consent. Since the feasibility of this approach is being tested, as many participants as possible will be included from the pool of people that attend participating healthcare centers during the study period.
Who may be able to join
- Show any suggestive symptoms of gHAT, such as headache (>14 days), long-term fever unless other obvious cause(s), malaise, weakness, arthralgia, facial edema, pruritus, lymphadenopathy, weight loss, mental confussion, abnormal behavior, logorrhea, speech impairment, anxiety, tremor, motor weakness, ataxia, abnormal gait, abnormal movements or seizures;
- Being older than 6 years old and weighing at least 20 kg;
- Willing and able to provide written informed consent (assent for minors);
- Minors (6 to 17 years old) willing and able to provide a written assent, after obtaining written informed consent from their parents.
Who cannot join
- Being younger than 6 years old or weighing less than 20 kg;
- Refusal to provide informed consent;
- Previously treated for HAT (questionnaire to patients and/or family members);
- Pregnant women.
About this study
Official title: Screen and Treat Implementation in Insecure Areas With Limited Capacities for HAT Control
Human African Trypanosomiasis (HAT), or sleeping sickness, is one of the parasitic diseases targeted for interruption of transmission by 2030 by the WHO. The development of fexinidazole as treatment is a huge step towards this achievement; however, the diagnostic algorithm remains complex due to limited sensitivity and specificity of the available tests. A combination of serological screening and confirmation of infection through parasite visualization remains the preferred strategy, although it can be difficult to ensure its full performance in areas that are hard to reach or have limited access to electricity and other means.
The present study would like to test an approach of ensuring treatment with fexinidazole of sero-suspects without confirmation of disease, among patients that consult fixed health infrastructures in the provinces of Maniema, Lomami and Tanganyika. This should enable access to gHAT treatment for patients living in hard to reach areas, actively seeking health care.
Read the detailed description
In this study, all gHAT suspects that attend participating health facilities with suggestive symptoms and test positive in an antibody detection rapid test, will presumptively be treated with fexinidazole. Blood samples will be collected for the post-hoc confirmation of the infection. Nine Health facilities have been selected in the health zones of Kasongo, Kibombo, Kunda and Samba (province of Maniema), Kongolo (province of Tanganyika) and Lubao (province of Lomami) by the PNLTHA, and ITM, based on both epidemiological data and operational considerations.
All patients that consult the selected facilities showing any symptom that could be attributed to gHAT will be offered to participate in the study and kindly requested to provide informed consent. Participants will be tested using the rapid diagnostic test (RDT) HAT Sero-K-SeT. All positive individuals will be asked to provide a venous blood sample, that will be sent to the Institut National de Recherche Biomédical (INRB) or Centre de Recherche en Santé de Kimpese (CRSK) for further serological testing with iELISA and/or immune trypanolysis (TL) and to confirm diagnosis with molecular testing. They will also be offered a 10-day fexinidazole treatment, as inpatient. After treatment, the study participants will be asked to return to the health facility after six months for a clinical follow-up.
Two follow -up visits (3 and 6 months) will be actively organized for all patients with a positive result in iELISA and/or molecular tests conducted at INRB/Kimpese laboratory, through active tracing by health facilities and community members. At the 3 month visit, a clinical examination and DNA/RNA sampling for molecular testing will be performed. At the 6 month visit, adverse events and disease status will be assessed based on clinical signs or symptoms. After the 6-month visit, all patients with a confirmed gHAT infection will be invited to come back to health facility 12, 18 and 24 months after treatment, following WHO guidelines, to confirm cure.
- Conditions
- Sleeping Sickness, Trypanosomiasis, African
- Being tested
- Screen&treat
- Keywords
- Sleeping sickness, Human African Trypanosomiasis, Fexinidazole
- Medical subject headings
- Trypanosomiasis, African
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screen&treatOther
Study participants will be tested with an RDT to prove the presence of antibodies against Trypanosoma brucei gambiense. Should the RDT be positive, they will be offered the 10-day treatment with fexinidazole, and an additional blood sample will be taken for the post hoc confirmation of the disease.
| Study group | Role | What they receive |
|---|---|---|
| People with symptoms attributable to gHAT | The study will include any person that attends any of the participating healthcare facilities with symptoms that could be attributed to gHAT (long-term fever (unless other obvious causes), headache for a long period (more than 14 days), presence of enlarged lymph nodes in the neck, severe weight loss, weakness, pruritus, amenorrhea, abortions or sterility, psychiatric problems (aggressiveness, apathy, mental confusion, anxiety), sleep disturbances, motor weakness, logorrhea, speech impairment, ataxia, abnormal gait, abnormal movements or seizures) and accepts to participate. Receives: Other: Screen&treat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the feasibility of an alternative operational approach for the diagnosis and treatment of gHAT patients in areas with limited access and diagnostic capacities.
This qualitative study will assess:
- Number of people with suggestive symptoms;
- Number of participants that test positive in the rapid diagnostic test;
- Number of sero-positive individuals who accept fexinidazole treatment and
- Number of treated individuals who test positive in further serological/molecular tests.
Measured: 11 months
Secondary outcomes (2)
Assess gHAT transmission in the provinces of Maniema, Tanganyka and partially Lomami.
Based on the number of sero-positive individuals and confirmed infections, calculate gHAT incidence in the study areas.
Measured: 11 months
Contribute to the collection of evidence of the use of fexinidazole.
The frequency and severity of any adverse effect due to the fexinidazole treatment will be recorded by a healthcare professional during the 10-day regime as well as in the 6-month follow-up visit.
Measured: 11 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Jan 2024
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Why it stopped: There is a problem with the provision of the treatment, we are unable to provide sufficient number of treatments for the study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleeping SicknessStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Public Health, Democratic Republic of the Congo, Institut National de Recherche Biomedicale (INRB), SANRU Asbl, Soins de Santé Primaires en Milieu Rural, République Démocratique du Congo, Drugs for Neglected Diseases
- Responsible party
- Sponsor
- Investigators
- Raquel Inocencio da Luz, PhD, Principal investigator, Institute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645822
- Sponsor's protocol ID
- Screen&treat
- Status last verified
- Jan 2024
- First submitted
- 30 Nov 2022
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screen and Treat Implementation in Insecure Areas With Limited Capacities for HAT Control
- ClinicalTrials.gov ID
- NCT05645822
- Acronym / sponsor ID
- Screen&treat
- Conditions
- Sleeping Sickness, Trypanosomiasis, African
- Keywords
- Sleeping sickness, Human African Trypanosomiasis, Fexinidazole
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: There is a problem with the provision of the treatment, we are unable to provide sufficient number of treatments for the study participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Ministry of Public Health, Democratic Republic of the Congo, Institut National de Recherche Biomedicale (INRB), SANRU Asbl, Soins de Santé Primaires en Milieu Rural, République Démocratique du Congo, Drugs for Neglected Diseases
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 12 Dec 2022 (actual)
- 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.
Human African Trypanosomiasis (HAT), or sleeping sickness, is one of the parasitic diseases targeted for interruption of transmission by 2030 by the WHO. The development of fexinidazole as treatment is a huge step towards this achievement; however, the diagnostic algorithm remains complex due to limited sensitivity and specificity of the available tests. A combination of serological screening and confirmation of infection through parasite visualization remains the preferred strategy, although it can be difficult to ensure its full performance in areas that are hard to reach or have limited access to electricity and other means.
The present study would like to test an approach of ensuring treatment with fexinidazole of sero-suspects without confirmation of disease, among patients that consult fixed health infrastructures in the provinces of Maniema, Lomami and Tanganyika. This should enable access to gHAT treatment for patients living in hard to reach areas, actively seeking health care.
Detailed description
In this study, all gHAT suspects that attend participating health facilities with suggestive symptoms and test positive in an antibody detection rapid test, will presumptively be treated with fexinidazole. Blood samples will be collected for the post-hoc confirmation of the infection. Nine Health facilities have been selected in the health zones of Kasongo, Kibombo, Kunda and Samba (province of Maniema), Kongolo (province of Tanganyika) and Lubao (province of Lomami) by the PNLTHA, and ITM, based on both epidemiological data and operational considerations.
All patients that consult the selected facilities showing any symptom that could be attributed to gHAT will be offered to participate in the study and kindly requested to provide informed consent. Participants will be tested using the rapid diagnostic test (RDT) HAT Sero-K-SeT. All positive individuals will be asked to provide a venous blood sample, that will be sent to the Institut National de Recherche Biomédical (INRB) or Centre de Recherche en Santé de Kimpese (CRSK) for further serological testing with iELISA and/or immune trypanolysis (TL) and to confirm diagnosis with molecular testing. They will also be offered a 10-day fexinidazole treatment, as inpatient. After treatment, the study participants will be asked to return to the health facility after six months for a clinical follow-up.
Two follow -up visits (3 and 6 months) will be actively organized for all patients with a positive result in iELISA and/or molecular tests conducted at INRB/Kimpese laboratory, through active tracing by health facilities and community members. At the 3 month visit, a clinical examination and DNA/RNA sampling for molecular testing will be performed. At the 6 month visit, adverse events and disease status will be assessed based on clinical signs or symptoms. After the 6-month visit, all patients with a confirmed gHAT infection will be invited to come back to health facility 12, 18 and 24 months after treatment, following WHO guidelines, to confirm cure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with symptoms attributable to gHAT | – | Other: Screen&treatThe study will include any person that attends any of the participating healthcare facilities with symptoms that could be attributed to gHAT (long-term fever (unless other obvious causes), headache for a long period (more than 14 days), presence of enlarged lymph nodes in the neck, severe weight loss, weakness, pruritus, amenorrhea, abortions or sterility, psychiatric problems (aggressiveness, apathy, mental confusion, anxiety), sleep disturbances, motor weakness, logorrhea, speech impairment, ataxia, abnormal gait, abnormal movements or seizures) and accepts to participate. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 9 health facilities in the endemic health zones of Kasongo, Kikombo, Kunda and Samba in the province of Maniema, Kongolo in the province of Tanganyika and Lubao in the province of Lomami are selected based on reported HAT cases 3 years prior, where fexinidazole treatment has been provided through PNLTHA or DNDi and where sample transport will be ensured by the NGO SANRU, despite difficult accessibility. The study aims to include every person that attends the participating fixed healthcare facilitie with suggestive symptoms of gHAT (see above) and is willing to provide informed consent. Since the feasibility of this approach is being tested, as many participants as possible will be included from the pool of people that attend participating healthcare centers during the study period.
Key inclusion criteria (4 listed)
- Show any suggestive symptoms of gHAT, such as headache (>14 days), long-term fever unless other obvious cause(s), malaise, weakness, arthralgia, facial edema, pruritus, lymphadenopathy, weight loss, mental confussion, abnormal behavior, logorrhea, speech impairment, anxiety, tremor, motor weakness, ataxia, abnormal gait, abnormal movements or seizures;
- Being older than 6 years old and weighing at least 20 kg;
- Willing and able to provide written informed consent (assent for minors);
- Minors (6 to 17 years old) willing and able to provide a written assent, after obtaining written informed consent from their parents.
Key exclusion criteria (4 listed)
- Being younger than 6 years old or weighing less than 20 kg;
- Refusal to provide informed consent;
- Previously treated for HAT (questionnaire to patients and/or family members);
- Pregnant women.
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 |
|---|---|---|
| Screen&treatStudy participants will be tested with an RDT to prove the presence of antibodies against Trypanosoma brucei gambiense. Should the RDT be positive, they will be offered the 10-day treatment with fexinidazole, and an additional blood sample will be taken for the post hoc confirmation of the disease. | Other | People with symptoms attributable to gHAT |
Primary outcome
Assess the feasibility of an alternative operational approach for the diagnosis and treatment of gHAT patients in areas with limited access and diagnostic capacities.
Time frame: 11 months
This qualitative study will assess: * Number of people with suggestive symptoms; * Number of participants that test positive in the rapid diagnostic test; * Number of sero-positive individuals who accept fexinidazole treatment and * Number of treated individuals who test positive in further serological/molecular tests.
2 secondary outcomes
Assess gHAT transmission in the provinces of Maniema, Tanganyka and partially Lomami.
Time frame: 11 months
Contribute to the collection of evidence of the use of fexinidazole.
Time frame: 11 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Raquel Inocencio da Luz, PhD principal investigator
Institute of Tropical Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Sleeping Sickness and Trypanosomiasis, African, run by Institute of Tropical Medicine, Belgium.
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: withdrawn, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Assess the feasibility of an alternative operational approach for the diagnosis and treatment of gHAT patients in areas with limited access and diagnostic capacities. (time frame: 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2024.