Visceral LeishmaniasisNCT01766830
Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases In Patients With Persistent Fever in Cambodia, Nepal, Democratic Republic of the Congo and Sudan (NIDIAG-Fever)
A study testing rk28 ICT, IT LEISH (rK39) and Immunochromatographic HAT test in people with Visceral Leishmaniasis and Human African Trypanosomiasis, run by University Hospital, Geneva at 7 sites in 4 countries.
Trial summary
Tropical fevers have been a diagnostic challenge from the antiquity. Nowadays, despite the availability of good diagnostic capacities, undifferentiated febrile illnesses continue to be a thorny problem for travel physicians. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Visceral Leishmaniasis, Human African Trypanosomiasis, Enteric Fever
- What is being tested?
- rk28 ICT, IT LEISH (rK39) and Immunochromatographic HAT test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,927 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Jan 2013to Jul 2016
- Phase
- Interventional
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- fever for ≥ 1 week
- ≥ 5 years old (18 years onward in Cambodia)
Who cannot join
- unwilling or unable to give written informed consent
- unable in the study physician's opinion to comply with the study requirements
- existing laboratory confirmed diagnosis
- need of immediate intensive care due to shock or respiratory distress
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Democratic Republic of the Congo2 sites
Institut National de Recherche Biomédicale
Kinshasa
Reference Hospital Mosango and Kasay Health Centre
Mosango, Bandundu
Nepal2 sites
Dhankuta District hospital
Dhankuta, Koshi Zone
BP Koirala Institute of Health Sciences
Dharān
Sudan2 sites
University of Khartoum
Khartoum
Tabarak Allah Hospital
Tabarak Allah, Al Qaḑārif
About this study
Official title: Evaluation of Rapid Diagnostic Tests (RDT) in Association With Clinical and Laboratory Predictors for the Diagnosis of Neglected Tropical Diseases (NTD) in Patients Presenting With Persistent Fever (≥1 Week) in Cambodia, Nepal, Democratic Republic of the Congo and Sudan
Tropical fevers have been a diagnostic challenge from the antiquity. Nowadays, despite the availability of good diagnostic capacities, undifferentiated febrile illnesses continue to be a thorny problem for travel physicians. In developing countries, the scarcity of skilled personnel and adequate laboratory facilities makes the differential diagnosis of fevers even more complex. Health care workers must often rely on syndrome-oriented empirical approaches to treatment and might overestimate or underestimate the likelihood of certain diseases. For instance Neglected Tropical Diseases (NTD) contribute substantially to the burden of persistent (more than 1 week) fevers in the Tropics, causing considerable mortality and major disability. These diseases are however rarely diagnosed at primary health care (PHC) level. The difficulty in establishing the cause of febrile illnesses has resulted in omission or delays in treatment, irrational prescriptions with polytherapy, increasing cost and development of drug resistance.
In resource-limited settings, clinical algorithms constitute a valuable aid to health workers, as they facilitate the therapeutic decision in the absence of good laboratory capacities. There is a critical lack of appropriate diagnostic tools to guide treatment of NTDs. While clinical algorithms have been developed for some NTDs, in most cases they remain empirical. Besides, they rarely take into account local prevalence data, do not adequately represent the spectrum of patients and differential diagnosis at the primary care level and often have not been properly validated. The purpose of the study is to develop evidence-based Rapid Diagnostic Test (RDT)-supported diagnostic guidelines for patients with persistent fever (≥ 1 week) in the Democratic Republic of the Congo (DRC), Sudan, Cambodia and Nepal.
Read the detailed description
This study is part of a large European Union (EU)-funded research project called NIDIAG that aims at developing integrated, evidence-based syndromic approach to improve management of NTD-related clinical syndromes. NIDIAG targets three non-specific clinical syndromes: the persistent fever, neurological, and intestinal syndrome. The objective of the project is to establish diagnostic guidelines for each of this syndrome, with a particular focus on severe and treatable neglected infectious diseases. The developed guidelines should integrate relevant Point-of-Care (POC)tests.
The persistent fever syndrome targeted by NIDIAG is defined as presence of fever for at least one week. The list of diseases - both NTD and other Infectious Diseases (ID) - that frequently cause persistent (≥1 week) fever in the study countries includes: Visceral Leishmaniasis (VL), Human Africa Trypanosomiasis (HAT), Enteric (typhoid, paratyphoid) fever, Malaria, Brucellosis, Melioidosis, Tuberculosis, Amoebic liver abscess, Relapsing fever, HIV, Rickettsial diseases, and Leptospirosis. The study will try to identify clinical and laboratory predictors of these diseases as well as validate existing RDTs.
- Conditions
- Visceral Leishmaniasis, Human African Trypanosomiasis, Enteric Fever, Melioidosis, Brucellosis, Leptospirosis
- Being tested
- rk28 ICT, IT LEISH (rK39), Immunochromatographic HAT test, HAT Serostrip, Card Agglutination Trypanosoma Test (CATT)-10
- Medical subject headings
- Leishmaniasis, Visceral, Typhoid Fever, Melioidosis, Brucellosis, Leptospirosis, Relapsing Fever, Rickettsia Infections, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rk28 ICTDevice
rk28 ICT is an immunochromatographic assay intended for qualitative detection of IgG antibodies directed towards VL in human serum, plasma or whole blood. It is manufactured by EASE-Medtrend (Shanghai, China)
IT LEISH (rK39)Device
IT LEISH is an immuno-chromatographic test, using the recombinant antigen K39, to detect the presence of antibodies against Leishmania spp. It is manufactured by BioRad laboratories, USA.
Immunochromatographic HAT testDevice
This is a lateral flow immunochromatographic test manufactured by Standard Diagnostics (Korea) in collaboration with FIND.
HAT SerostripDevice
The HAT Serostrip is an immunochromatographic assay developed by Coris BioConcept, France, which is designed for remote field use in individual HAT suspects.
Card Agglutination Trypanosoma Test (CATT)-10Device
The Card Agglutination Trypanosoma test (CATT) has been used for many years at large scale for mass screening of mostly asymptomatic individuals (CATT-R250). Unfortunately, its operating characteristics have only been evaluated in the context of patients with persistent fever. Although it is not strictly an RDT, the CATT is rather easily performed in remote settings, in particular since a new and more robust format (CATT-D10) allows to test a lower number of patients in peripheral health facilities. It is manufactured by the Institute of Tropical Medicine of Antwerp, Belgium.
Typhidot MDevice
The Typhidot M test is a dot enzyme immunoassay that detects IgM and IgG directed against Salmonella typhi. It is manufactured by Reszon Diagnostics International, Malaysia
S. typhi IgM/IgGDevice
The Salmonella typhi IgG/IgM Rapid Test is an immunochromatographic assay for the qualitative differential detection of IgG and IgM antibodies to Salmonella typhi in human serum, plasma or whole blood. It is manufactured by Standard Diagnostics (Korea)
Test-it Typhoid IgMDevice
Test-it Typhoid IgM lateral flow assay is a one-step immunochromatographic assay which uses a lipopolysaccharide (LPS) antigen derived from salmonella typhi for the detection of specific IgM antibodies. It is manufactured by Life Assay, South Africa.
Test-it Leptospirosis IgMDevice
The Test-it™ Leptospira lateral flow device detects IgM antibodies in humans against Leptospira in whole blood or serum. It is manufactured by Life Assay, South Africa
Leptospira IgG/IgMDevice
This test enables the differential detection of IgG and IgM antibodies to Leptospira interrogans. It is manufactured by Standard Diagnostics, Korea
| Study group | Role | What they receive |
|---|---|---|
| Phase 3 Diagnostic | Experimental | A total of 10 RDTs will be assessed in the patients cohort for the respective target condition Receives: Device: rk28 ICT; Device: IT LEISH (rK39); Device: Immunochromatographic HAT test; Device: HAT Serostrip; Device: Card Agglutination Trypanosoma Test (CATT)-10; Device: Typhidot M; Device: S. typhi IgM/IgG; Device: Test-it Typhoid IgM; Device: Test-it Leptospirosis IgM; Device: Leptospira IgG/IgM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Visceral Leishmaniasis (VL), Human African Trypanosomiasis (HAT) and other Neglected Tropical Diseases (NTDs)
Number of patients diagnosed with VL, HAT and other NTDs among those presenting with persistent(≥ 1 week) fever in one of the study sites
Measured: 18 months
Identification of clinical and laboratory diagnostic indicators
Sensitivity, specificity, crude and adjusted likelihoods ratios (LR), and predictive values (post-test probabilities) of clinical and first-line laboratory predictors for the diagnosis of VL, HAT and other NTDs
Measured: 18 months
Identification of reliable Rapid Diagnostic Tests (RDTs)
Assessment of sensitivity, likelihood ratios and performances (diagnostic accuracy) of the novel study RDTs for VL, HAT, enteric fever and
Measured: 18 months
Predictive values of RDTs
Predictive values (post-test probabilities) of RDTs, alone and in combination, for the respective target conditions within the multi-disease approach
Measured: 18 months
Secondary outcomes (1)
Cost-effectiveness of the diagnostic tests
Unit costs of diagnostic tests for the diagnosis of HAT and other priority NTDs/IDs in the setting
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2014
- Study completionJul 2016
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 Visceral LeishmaniasisStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,927 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium, B.P. Koirala Institute of Health Sciences, Institut National de Recherche Biomedicale (INRB), University of Khartoum, Sihanouk Hospital Center of HOPE
- Responsible party
- Principal investigator, Francois CHAPPUIS, University Hospital, Geneva
- Investigators
- François Chappuis, MD, PhD, Study director, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766830
- Sponsor's protocol ID
- WP2-01-FEV
- Other IDs
- 260260
- Status last verified
- Oct 2016
- First submitted
- 9 Jan 2013
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bottieau E, Van Duffel L, El Safi S, Koirala KD, Khanal B, Rijal S, Bhattarai NR, Phe T, Lim K, Mukendi D, Kalo JL, Lutumba P, Barbe B, Jacobs J, Van Esbroeck M, Foque N, Tsoumanis A, Parola P, Yansouni CP, Boelaert M, Verdonck K, Chappuis F. Etiological spectrum of persistent fever in the tropics and predictors of ubiquitous infections: a prospective four-country study with pooled analysis. BMC Med. 2022 May 2;20(1):144. doi: 10.1186/s12916-022-02347-8.
PubMed 35491421Alirol E, Horie NS, Barbe B, Lejon V, Verdonck K, Gillet P, Jacobs J, Buscher P, Kanal B, Bhattarai NR, El Safi S, Phe T, Lim K, Leng L, Lutumba P, Mukendi D, Bottieau E, Boelaert M, Rijal S, Chappuis F. Diagnosis of Persistent Fever in the Tropics: Set of Standard Operating Procedures Used in the NIDIAG Febrile Syndrome Study. PLoS Negl Trop Dis. 2016 Nov 3;10(11):e0004749. doi: 10.1371/journal.pntd.0004749. eCollection 2016 Nov.
PubMed 27812090
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rapid Diagnostic Tests (RDT) in Association With Clinical and Laboratory Predictors for the Diagnosis of Neglected Tropical Diseases (NTD) in Patients Presenting With Persistent Fever (≥1 Week) in Cambodia, Nepal, Democratic Republic of the Congo and Sudan
- ClinicalTrials.gov ID
- NCT01766830
- Acronym / sponsor ID
- WP2-01-FEV
- Conditions
- Visceral Leishmaniasis, Human African Trypanosomiasis, Enteric Fever, Melioidosis, Brucellosis, Leptospirosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,927 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium, B.P. Koirala Institute of Health Sciences, Institut National de Recherche Biomedicale (INRB), University of Khartoum, Sihanouk Hospital Center of HOPE
- Study start
- Jan 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Jan 2013 (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.
Tropical fevers have been a diagnostic challenge from the antiquity. Nowadays, despite the availability of good diagnostic capacities, undifferentiated febrile illnesses continue to be a thorny problem for travel physicians. In developing countries, the scarcity of skilled personnel and adequate laboratory facilities makes the differential diagnosis of fevers even more complex. Health care workers must often rely on syndrome-oriented empirical approaches to treatment and might overestimate or underestimate the likelihood of certain diseases. For instance Neglected Tropical Diseases (NTD) contribute substantially to the burden of persistent (more than 1 week) fevers in the Tropics, causing considerable mortality and major disability. These diseases are however rarely diagnosed at primary health care (PHC) level. The difficulty in establishing the cause of febrile illnesses has resulted in omission or delays in treatment, irrational prescriptions with polytherapy, increasing cost and development of drug resistance.
In resource-limited settings, clinical algorithms constitute a valuable aid to health workers, as they facilitate the therapeutic decision in the absence of good laboratory capacities. There is a critical lack of appropriate diagnostic tools to guide treatment of NTDs. While clinical algorithms have been developed for some NTDs, in most cases they remain empirical. Besides, they rarely take into account local prevalence data, do not adequately represent the spectrum of patients and differential diagnosis at the primary care level and often have not been properly validated. The purpose of the study is to develop evidence-based Rapid Diagnostic Test (RDT)-supported diagnostic guidelines for patients with persistent fever (≥ 1 week) in the Democratic Republic of the Congo (DRC), Sudan, Cambodia and Nepal.
Detailed description
This study is part of a large European Union (EU)-funded research project called NIDIAG that aims at developing integrated, evidence-based syndromic approach to improve management of NTD-related clinical syndromes. NIDIAG targets three non-specific clinical syndromes: the persistent fever, neurological, and intestinal syndrome. The objective of the project is to establish diagnostic guidelines for each of this syndrome, with a particular focus on severe and treatable neglected infectious diseases. The developed guidelines should integrate relevant Point-of-Care (POC)tests.
The persistent fever syndrome targeted by NIDIAG is defined as presence of fever for at least one week. The list of diseases - both NTD and other Infectious Diseases (ID) - that frequently cause persistent (≥1 week) fever in the study countries includes: Visceral Leishmaniasis (VL), Human Africa Trypanosomiasis (HAT), Enteric (typhoid, paratyphoid) fever, Malaria, Brucellosis, Melioidosis, Tuberculosis, Amoebic liver abscess, Relapsing fever, HIV, Rickettsial diseases, and Leptospirosis. The study will try to identify clinical and laboratory predictors of these diseases as well as validate existing RDTs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 3 Diagnostic | Experimental | Device: rk28 ICT, Device: IT LEISH (rK39), Device: Immunochromatographic HAT test, Device: HAT Serostrip, Device: Card Agglutination Trypanosoma Test (CATT)-10, Device: Typhidot M, Device: S. typhi IgM/IgG, Device: Test-it Typhoid IgM, Device: Test-it Leptospirosis IgM, Device: Leptospira IgG/IgMA total of 10 RDTs will be assessed in the patients cohort for the respective target condition |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- fever for ≥ 1 week
- ≥ 5 years old (18 years onward in Cambodia)
Key exclusion criteria (4 listed)
- unwilling or unable to give written informed consent
- unable in the study physician's opinion to comply with the study requirements
- existing laboratory confirmed diagnosis
- need of immediate intensive care due to shock or respiratory distress
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 |
|---|---|---|
| rk28 ICTrk28 ICT is an immunochromatographic assay intended for qualitative detection of IgG antibodies directed towards VL in human serum, plasma or whole blood. It is manufactured by EASE-Medtrend (Shanghai, China) | Device | Phase 3 Diagnostic |
| IT LEISH (rK39)IT LEISH is an immuno-chromatographic test, using the recombinant antigen K39, to detect the presence of antibodies against Leishmania spp. It is manufactured by BioRad laboratories, USA. | Device | Phase 3 Diagnostic |
| Immunochromatographic HAT testThis is a lateral flow immunochromatographic test manufactured by Standard Diagnostics (Korea) in collaboration with FIND. | Device | Phase 3 Diagnostic |
| HAT SerostripThe HAT Serostrip is an immunochromatographic assay developed by Coris BioConcept, France, which is designed for remote field use in individual HAT suspects. | Device | Phase 3 Diagnostic |
| Card Agglutination Trypanosoma Test (CATT)-10The Card Agglutination Trypanosoma test (CATT) has been used for many years at large scale for mass screening of mostly asymptomatic individuals (CATT-R250). Unfortunately, its operating characteristics have only been evaluated in the context of patients with persistent fever. Although it is not strictly an RDT, the CATT is rather easily performed in remote settings, in particular since a new and more robust format (CATT-D10) allows to test a lower number of patients in peripheral health facilities. It is manufactured by the Institute of Tropical Medicine of Antwerp, Belgium. | Device | Phase 3 Diagnostic |
| Typhidot MThe Typhidot M test is a dot enzyme immunoassay that detects IgM and IgG directed against Salmonella typhi. It is manufactured by Reszon Diagnostics International, Malaysia | Device | Phase 3 Diagnostic |
| S. typhi IgM/IgGThe Salmonella typhi IgG/IgM Rapid Test is an immunochromatographic assay for the qualitative differential detection of IgG and IgM antibodies to Salmonella typhi in human serum, plasma or whole blood. It is manufactured by Standard Diagnostics (Korea) | Device | Phase 3 Diagnostic |
| Test-it Typhoid IgMTest-it Typhoid IgM lateral flow assay is a one-step immunochromatographic assay which uses a lipopolysaccharide (LPS) antigen derived from salmonella typhi for the detection of specific IgM antibodies. It is manufactured by Life Assay, South Africa. | Device | Phase 3 Diagnostic |
| Test-it Leptospirosis IgMThe Test-it™ Leptospira lateral flow device detects IgM antibodies in humans against Leptospira in whole blood or serum. It is manufactured by Life Assay, South Africa | Device | Phase 3 Diagnostic |
| Leptospira IgG/IgMThis test enables the differential detection of IgG and IgM antibodies to Leptospira interrogans. It is manufactured by Standard Diagnostics, Korea | Device | Phase 3 Diagnostic |
Primary outcome
Prevalence of Visceral Leishmaniasis (VL), Human African Trypanosomiasis (HAT) and other Neglected Tropical Diseases (NTDs)
Time frame: 18 months
Number of patients diagnosed with VL, HAT and other NTDs among those presenting with persistent(≥ 1 week) fever in one of the study sites
Identification of clinical and laboratory diagnostic indicators
Time frame: 18 months
Sensitivity, specificity, crude and adjusted likelihoods ratios (LR), and predictive values (post-test probabilities) of clinical and first-line laboratory predictors for the diagnosis of VL, HAT and other NTDs
Identification of reliable Rapid Diagnostic Tests (RDTs)
Time frame: 18 months
Assessment of sensitivity, likelihood ratios and performances (diagnostic accuracy) of the novel study RDTs for VL, HAT, enteric fever and
Predictive values of RDTs
Time frame: 18 months
Predictive values (post-test probabilities) of RDTs, alone and in combination, for the respective target conditions within the multi-disease approach
1 secondary outcome
Cost-effectiveness of the diagnostic tests
Time frame: 18 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 27 Oct 2016.
- Derived from this study: PubMed 35491421Bottieau E, Van Duffel L, El Safi S, Koirala KD, Khanal B, Rijal S, Bhattarai NR, Phe T, Lim K, Mukendi D, Kalo JL, Lutumba P, Barbe B, Jacobs J, Van Esbroeck M, Foque N, Tsoumanis A, Parola P, Yansouni CP, Boelaert M, Verdonck K, Chappuis F. Etiological spectrum of persistent fever in the tropics and predictors of ubiquitous infections: a prospective four-country study with pooled analysis. BMC Med. 2022 May 2;20(1):144. doi: 10.1186/s12916-022-02347-8.
- Derived from this study: PubMed 27812090Alirol E, Horie NS, Barbe B, Lejon V, Verdonck K, Gillet P, Jacobs J, Buscher P, Kanal B, Bhattarai NR, El Safi S, Phe T, Lim K, Leng L, Lutumba P, Mukendi D, Bottieau E, Boelaert M, Rijal S, Chappuis F. Diagnosis of Persistent Fever in the Tropics: Set of Standard Operating Procedures Used in the NIDIAG Febrile Syndrome Study. PLoS Negl Trop Dis. 2016 Nov 3;10(11):e0004749. doi: 10.1371/journal.pntd.0004749. eCollection 2016 Nov.
- NIDIAG Consortium websiteLink provided by the sponsor.
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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.
François Chappuis, MD, PhD study director
University Hospital, Geneva
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rk28 ICT, IT LEISH (rK39) and Immunochromatographic HAT test in people with Visceral Leishmaniasis and Human African Trypanosomiasis, run by University Hospital, Geneva at 7 sites in 4 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 2 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Democratic Republic of the Congo, Nepal, Sudan, Cambodia. 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?
Prevalence of Visceral Leishmaniasis (VL), Human African Trypanosomiasis (HAT) and other Neglected Tropical Diseases (NTDs) (time frame: 18 months). The study lists 4 primary outcomes in all. 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 NCT01766830, 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 27 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.