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Soil-transmitted HelminthiasisNIDIAGDigestNCT02105714

Diagnosis of Neglected Tropical Diseases Among Patients With Persistent Digestive Disorders

An observational study of Soil-transmitted Helminthiasis and Schistosomiasis, run by Swiss Tropical & Public Health Institute at 7 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

NIDIAG is an international collaboration on integrated diagnosis-treatment platforms, funded by the European Commission (EC). NIDIAG aims to develop an improved, patient-centred system for delivering primary health care in resource-constrained settings. Read more about this study

Who is it for?
Ages 1 year and olderHealthy volunteers can take part
What is being tested?
Stool culturing for pathogenic bacteria, Kato-Katz technique and Baermann technique
How many people
2,800 participants
Where
7 sitesin 4 countries
Study dates
Jul 2014to May 2016
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 1 year and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Individuals aged ≥1 year presenting with persistent diarrhoea (≥3 loose stools per days for ≥2 weeks; symptomatic group) and/or children (aged 1-18 years) with persistent abdominal pain (localized or diffuse abdominal pain lasting for ≥2 weeks, with possible intermittence/recurrence) will be recruited together with matched controls.

Who may be able to join

  • Individuals aged ≥1 year presenting with persistent diarrhoea (≥3 loose stools per days for ≥2 weeks; symptomatic group) and/or children (aged 1-18 years) with persistent abdominal pain (localized or diffuse abdominal pain lasting for ≥2 weeks, with possible intermittence/recurrence).
  • Individuals with written informed consent provided.

Who cannot join

  • Individuals in need of immediate intensive or surgical care.
  • Individuals who are unable or unwilling to give written informed consent.
  • Individuals who do not meet the inclusion criteria for being a case or control (e.g. people with acute diarrhoea).
  • Individuals with clinical jaundice (assessed by direct observation of the conjunctivae).
  • Individuals who are unable, in the study physician's opinion, to comply with the study requirements.
  • Individuals who are already participating in other ongoing diagnostic studies and/or clinical trials.

Trial locations and contacts

7 sites in 4 countries.

7 sites in 4 countries

Indonesia2 sites

  • Tulehu health center

    Maluku Tengah, Maluku

  • Tulehu hospital

    Maluku Tengah, Maluku

Other trials in Indonesia

Mali2 sites

  • Institut National de Recherche en Santé Publique

    Bamako, BP 1771

  • Niono District Reference Health Centre

    Niono

Other trials in Mali

Nepal2 sites

  • Dhankuta District Hospital

    Dhankuta

  • B.P. Koirala Institute of Health Sciences

    Dharān, 056700

Other trials in Nepal

Côte d’Ivoire1 site

  • Hôpital Méthodiste de Dabou

    Dabou

Other trials in Côte d’Ivoire

About this study

Official title: Diagnosis of Neglected Tropical Diseases (NTDs) in Patients Presenting With Persistent Digestive Disorders (≥2 Weeks) in Côte d'Ivoire, Indonesia, Mali and Nepal

NIDIAG is an international collaboration on integrated diagnosis-treatment platforms, funded by the European Commission (EC). NIDIAG aims to develop an improved, patient-centred system for delivering primary health care in resource-constrained settings. NIDIAG will investigate three clinical syndromes, namely (i) persistent digestive disorders, (ii) persistent fever and (iii) neurological disorders, due to neglected tropical diseases (NTDs). The current study focuses on persistent digestive disorders, which are defined as diarrhoea or abdominal pain that last for at least 2 weeks.

While acute diarrhoea has been studied globally, few research activities have focused on the epidemiology, diagnosis and treatment of long-lasting diarrhoeal episodes (2 weeks and longer) in the tropics. The spectrum of possibly involved pathogens includes more than 30 bacterial, parasitic and viral infectious agents. This lack of data may be explained by the fact that people suffering from NTDs might only seek care at a late stage of the disease. Furthermore, health systems in affected regions are often weak and their primary health-care centres are often under-staffed and lack essential diagnostic equipment.

The hypothesis of this study is that development of an evidence-based syndromic approach can lead to better diagnosis and management of NTDs in patients with persistent digestive disorders. The study will be carried out in two West African countries (Côte d'Ivoire and Mali) and in two Asian countries (Indonesia and Nepal). The study will follow a "case-control" design and patients and controls will be prospectively enrolled. In order to address the knowledge gaps, three specific objectives will be pursued. First, the contribution of NTDs to the 'persistent digestive disorders syndrome' will be assessed. Second, the value of clinical features and rapid diagnostic tests (RDTs) for the diagnosis of target NTDs that give rise to persistent digestive disorders will be determined. Third, the clinical response to standard empiric and targeted treatment of several NTDs in patients with persistent digestive disorders will be evaluated. These objectives will provide a long-term benefit for the communities by improving the clinical decision-making process for the target NTDs and thus, better diagnostic work-up and patient management can be achieved in the study countries and other similar resource-constrained countries

Being tested
Stool culturing for pathogenic bacteria, Kato-Katz technique, Baermann technique, Mini-FLOTAC, Crypto/Giardia Duo Strip
Keywords
Diarrhoea, Abdominal pain, Bacterial, Protozoal, Helminth
Medical subject headings
Schistosomiasis, Strongyloidiasis, Dysentery, Bacillary, Campylobacter Infections, Giardiasis, Amebiasis, Dientamoebiasis, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stool culturing for pathogenic bacteriaProcedure or surgery

  • Kato-Katz techniqueProcedure or surgery

  • Baermann techniqueProcedure or surgery

  • Mini-FLOTACDevice

  • Crypto/Giardia Duo StripDevice

  • Formalin-ether concentration techniqueProcedure or surgery

  • CCA RDTDevice

  • Koga agar plate cultureProcedure or surgery

  • Kinyoun stainingProcedure or surgery

  • Multiplex PCRDevice

  • Metagenomics analysisProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of neglected tropical diseases (NTDs) causing persistent digestive disorders (≥2 weeks)

    The frequency, distribution, and if possible, intensity of target NTDs

    Measured: 18 months

Secondary outcomes (1)

  1. Sensitivity, specificity, crude and adjusted likelihood ratios (LR) and predictive values (post-test probabilities) of clinical features and laboratory tests for the diagnosis of target NTDs

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionMar 2016
  4. Study completionMay 2016

Resources

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
2,800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02105714
Sponsor's protocol ID
WP2-01-DIG
Acronym
NIDIAGDigest
Status last verified
Oct 2016
First submitted
21 Mar 2014
Last updated
25 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • Kristanti H, Meyanti F, Wijayanti MA, Mahendradhata Y, Polman K, Chappuis F, Utzinger J, Becker SL, Murhandarwati EEH. Diagnostic comparison of Baermann funnel, Koga agar plate culture and polymerase chain reaction for detection of human Strongyloides stercoralis infection in Maluku, Indonesia. Parasitol Res. 2018 Oct;117(10):3229-3235. doi: 10.1007/s00436-018-6021-5. Epub 2018 Aug 3.

    PubMed 30074085

  • Polman K, Becker SL, Alirol E, Bhatta NK, Bhattarai NR, Bottieau E, Bratschi MW, Burza S, Coulibaly JT, Doumbia MN, Horie NS, Jacobs J, Khanal B, Landoure A, Mahendradhata Y, Meheus F, Mertens P, Meyanti F, Murhandarwati EH, N'Goran EK, Peeling RW, Ravinetto R, Rijal S, Sacko M, Saye R, Schneeberger PH, Schurmans C, Silue KD, Thobari JA, Traore MS, van Lieshout L, van Loen H, Verdonck K, von Muller L, Yansouni CP, Yao JA, Yao PK, Yap P, Boelaert M, Chappuis F, Utzinger J. Diagnosis of neglected tropical diseases among patients with persistent digestive disorders (diarrhoea and/or abdominal pain >/=14 days): Pierrea multi-country, prospective, non-experimental case-control study. BMC Infect Dis. 2015 Aug 18;15:338. doi: 10.1186/s12879-015-1074-x.

    PubMed 26282537

Questions about this trial

What is this clinical trial studying?

An observational study of Soil-transmitted Helminthiasis and Schistosomiasis, run by Swiss Tropical & Public Health Institute 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 6 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 25 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 Indonesia, Mali, Nepal, Côte d’Ivoire. 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 neglected tropical diseases (NTDs) causing persistent digestive disorders (≥2 weeks) (time frame: 18 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 NCT02105714, 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 25 Oct 2016.

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