Diagnosis of Neglected Tropical Diseases Among Patients With Persistent Digestive Disorders

NCT02105714 | Completed

• 1 other identifier: WP2-01-DIG
• Study Type: observational
• Target: 2,800
• Locations: 4 countries
• Sites: 7

Brief 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. 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

Conditions

Soil-transmitted Helminthiasis; Schistosomiasis; Strongyloidiasis; Shigellosis; Intestinal Salmonellosis; Campylobacteriosis; Aeromonas Spp. Infections; Giardiasis; Amoebiasis; Dientamoebiasis; Cryptosporidium Spp. Infections

Keywords

Diarrhoea; Abdominal pain; Bacterial; Protozoal; Helminth

Outcome Measures

Primary Outcomes (1)

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

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

  18 months

Secondary Outcomes (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

  18 months

Interventions

Stool culturing for pathogenic bacteria PROCEDURE

Kato-Katz technique PROCEDURE

Baermann technique PROCEDURE

Mini-FLOTAC DEVICE

Crypto/Giardia Duo Strip DEVICE

Formalin-ether concentration technique PROCEDURE

CCA RDT DEVICE

Koga agar plate culture PROCEDURE

Kinyoun staining PROCEDURE

Multiplex PCR DEVICE

Metagenomics analysis PROCEDURE

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Individuals in need of immediate intensive or surgical care.
• Individuals who are unable or unwilling to give written informed consent.
• 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.

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• Institute of Tropical Medicine, Belgium: collaborator
• B.P. Koirala Institute of Health Sciences: collaborator
• Université Félix Houphouët-Boigny: collaborator
• Institut de Recherche en Santé Publique, France: collaborator
• Gadjah Mada University: collaborator

Study Sites (7)

Hôpital Méthodiste de Dabou

Dabou, Côte d’Ivoire

Location

Tulehu health center

Maluku Tengah, Maluku, Indonesia

Location

Tulehu hospital

Maluku Tengah, Maluku, Indonesia

Location

Institut National de Recherche en Santé Publique

Bamako, BP 1771, Mali

Location

Niono District Reference Health Centre

Niono, Mali

Location

Dhankuta District Hospital

Dhankutā, Nepal

Location

B.P. Koirala Institute of Health Sciences

Dharān, 056700, Nepal

Location

Related Publications (2)

• 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.

  PMID: 30074085 DERIVED

• 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.

  PMID: 26282537 DERIVED

Related Links

• A pre-study for this trial

Biospecimen

Retention: SAMPLES WITH DNA

Ethanol-preserved human stool specimens

MeSH Terms

Conditions

Schistosomiasis; Strongyloidiasis; Dysentery, Bacillary; Campylobacter Infections; Giardiasis; Amebiasis; Dientamoebiasis; Diarrhea; Abdominal Pain

Interventions

Multiplex Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases; Rhabditida Infections; Secernentea Infections; Nematode Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Dysentery; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Intestinal Diseases, Parasitic; Protozoan Infections; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Officials

• Jürg Utzinger, PhD

  Swiss Tropical & Public Health Institute

  PRINCIPAL INVESTIGATOR

• Katja Polman, PhD

  Institute of Tropical Medicine, Belgium

  PRINCIPAL INVESTIGATOR

• Marleen Boelaert, PhD

  Institute of Tropical Medicine, Belgium

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: April 7, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

MA (2); ID (2); NE (2); CÔ (1)