Diagnosis of Neglected Tropical Diseases Among Patients With Persistent Digestive Disorders

Schistosomiasis Clinical Trial

— NIDIAGDigest  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105714
• Other study ID #: WP2-01-DIG
• Status: Completed
• Phase: N/A
• First received: March 21, 2014
• Last updated: October 24, 2016
• Start date: July 2014
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionMali: comités d'éthiqueCote d'Ivoire: National Research and Ethics CommitteeNepal: Health Research CouncilIndonesia: Ethics Committee
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2800
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aeromonas Spp. Infections
• Amebiasis
• Amoebiasis
• Campylobacter Infections
• Campylobacteriosis
• Communicable Diseases
• Cryptosporidium Spp. Infections
• Dientamoebiasis
• Digestive System Diseases
• Dysentery, Bacillary
• Giardiasis
• Helminthiasis
• Infection
• Intestinal Salmonellosis
• Salmonella Infections
• Schistosomiasis
• Shigellosis
• Soil-transmitted Helminthiasis
• Strongyloidiasis

Intervention

Procedure:
• Stool culturing for pathogenic bacteria

• Kato-Katz technique

• Baermann technique

Device:
• Mini-FLOTAC

• Crypto/Giardia Duo Strip

Procedure:
• Formalin-ether concentration technique

Device:
• CCA RDT

Procedure:
• Koga agar plate culture

• Kinyoun staining

Device:
• Multiplex PCR

Procedure:
• Metagenomics analysis

Locations

Country	Name	City	State
Côte D'Ivoire	Hôpital Méthodiste de Dabou	Dabou
Indonesia	Tulehu health center	Maluku Tengah	Maluku
Indonesia	Tulehu hospital	Maluku Tengah	Maluku
Mali	Institut National de Recherche en Santé Publique	Bamako
Mali	Niono District Reference Health Centre	Niono
Nepal	Dhankuta District Hospital	Dhankuta
Nepal	B.P. Koirala Institute of Health Sciences	Dharan

Sponsors (6)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	B.P. Koirala Institute of Health Sciences, Gadjah Mada University, Institut National de Recherche en Santé Publique, Institute of Tropical Medicine, Belgium, Université Félix Houphouët-Boigny

Countries where clinical trial is conducted

Côte D'Ivoire,  Indonesia,  Mali,  Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of neglected tropical diseases (NTDs) causing persistent digestive disorders (=2 weeks)	The frequency, distribution, and if possible, intensity of target NTDs	18 months	No
Secondary	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	No