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Diagnosis of Neglected Tropical Diseases Among Patients With Persistent Digestive Disorders (NIDIAGDigest)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Swiss Tropical & Public Health Institute
Sponsor:
Collaborators:
Institute of Tropical Medicine, Belgium
B.P. Koirala Institute of Health Sciences
Université Félix Houphouët-Boigny, Abidjan
Institut National de Recherche en Santé Publique, Mali
Gadjah Mada University
Information provided by (Responsible Party):
Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier:
NCT02105714
First received: March 21, 2014
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Soil-transmitted Helminthiasis
Schistosomiasis
Strongyloidiasis
Shigellosis
Intestinal Salmonellosis
Campylobacteriosis
Aeromonas Spp. Infections
Giardiasis
Amoebiasis
Dientamoebiasis
Cryptosporidium Spp. Infections
Procedure: Stool culturing for pathogenic bacteria
Procedure: Kato-Katz technique
Procedure: Baermann technique
Device: Mini-FLOTAC
Device: Crypto/Giardia Duo Strip
Procedure: Formalin-ether concentration technique
Device: CCA RDT
Procedure: Koga agar plate culture
Procedure: Kinyoun staining
Device: Multiplex PCR
Procedure: Metagenomics analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Swiss Tropical & Public Health Institute:

Primary Outcome Measures:
  • Prevalence of neglected tropical diseases (NTDs) causing persistent digestive disorders (≥2 weeks) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The frequency, distribution, and if possible, intensity of target NTDs


Secondary Outcome Measures:
  • 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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: April 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

  1. 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).
  2. Individuals with written informed consent provided.

Exclusion Criteria:

  1. Individuals in need of immediate intensive or surgical care.
  2. Individuals who are unable or unwilling to give written informed consent.
  3. Individuals who do not meet the inclusion criteria for being a case or control (e.g. people with acute diarrhoea).
  4. Individuals with clinical jaundice (assessed by direct observation of the conjunctivae).
  5. Individuals who are unable, in the study physician's opinion, to comply with the study requirements.
  6. Individuals who are already participating in other ongoing diagnostic studies and/or clinical trials.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02105714

Locations
Côte D'Ivoire
Hôpital Méthodiste de Dabou Not yet recruiting
Dabou, Côte D'Ivoire
Contact: Joel Yao       yaojoel@yahoo.fr   
Principal Investigator: Eliézer N'Goran, PhD         
Indonesia
Tulehu health center Not yet recruiting
Maluku Tengah, Maluku, Indonesia
Contact: Elsa Herdiana, PhD       herdiana.elsa@gmail.com   
Principal Investigator: Yodi Mahendradhata, PhD         
Sub-Investigator: Fransiska Meyanti, PhD         
Tulehu hospital Not yet recruiting
Maluku Tengah, Maluku, Indonesia
Contact: Elsa Herdiana, PhD       herdiana.elsa@gmail.com   
Principal Investigator: Yodi Mahendradhata, PhD         
Sub-Investigator: Fransiska Meyanti, PhD         
Mali
Institut National de Recherche en Santé Publique Not yet recruiting
Bamako, Mali, BP 1771
Contact: Moussa Sacko, PhD       msacko@afribonemail.net   
Principal Investigator: Moussa Sacko, PhD         
Niono District Reference Health Centre Not yet recruiting
Niono, Mali
Contact: Moussa Sacko, PhD       msacko@afribonemail.net   
Principal Investigator: Moussa Sacko, PhD         
Nepal
Dhankuta District Hospital Not yet recruiting
Dhankuta, Nepal
Contact: Suman Rijal, Phd       sumanrijal2@yahoo.com   
Principal Investigator: Suman Rijal, PhD         
B.P. Koirala Institute of Health Sciences Not yet recruiting
Dharan, Nepal, 056700
Contact: Suman Rijal, PhD       sumanrijal2@yahoo.com   
Principal Investigator: Suman Rijal, PhD         
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
Institute of Tropical Medicine, Belgium
B.P. Koirala Institute of Health Sciences
Université Félix Houphouët-Boigny, Abidjan
Institut National de Recherche en Santé Publique, Mali
Gadjah Mada University
Investigators
Principal Investigator: Jürg Utzinger, PhD Swiss Tropical & Public Health Institute
Principal Investigator: Katja Polman, PhD Institute of Tropical Medicine, Belgium
Study Director: Marleen Boelaert, PhD Institute of Tropical Medicine, Belgium
  More Information

Additional Information:
No publications provided

Responsible Party: Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT02105714     History of Changes
Other Study ID Numbers: WP2-01-DIG
Study First Received: March 21, 2014
Last Updated: April 2, 2014
Health Authority: Switzerland: Ethikkommission
Mali: comités d'éthique
Cote d'Ivoire: National Research and Ethics Committee
Nepal: Health Research Council
Indonesia: Ethics Committee

Keywords provided by Swiss Tropical & Public Health Institute:
Diarrhoea
Abdominal pain
Bacterial
Protozoal
Helminth

Additional relevant MeSH terms:
Salmonella Infections
Amebiasis
Dysentery, Amebic
Campylobacter Infections
Dientamoebiasis
Digestive System Diseases
Dysentery, Bacillary
Giardiasis
Helminthiasis
Salmonella Food Poisoning
Schistosomiasis
Strongyloidiasis
Protozoan Infections
Parasitic Diseases
Intestinal Diseases, Parasitic
Dysentery
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Enterobacteriaceae Infections
Foodborne Diseases
Poisoning
Substance-Related Disorders
Trematode Infections
Rhabditida Infections
Secernentea Infections
Nematode Infections
Formaldehyde

ClinicalTrials.gov processed this record on July 20, 2014