Clinical trial NCT02105714: Diagnosis of Neglected Tropical Diseases Among Patients With Persistent Digestive Disorders
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Institute of Tropical Medicine, Belgium
name: B.P. Koirala Institute of Health Sciences
name: Université Félix Houphouët-Boigny
name: Institut de Recherche en Santé Publique, France
name: Gadjah Mada University
First posted: 2014-04-07
Enrollment: 2800
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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


Eligibility 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.

Primary outcomes:
measure: Prevalence of neglected tropical diseases (NTDs) causing persistent digestive disorders (≥2 weeks)
timeFrame: 18 months
Secondary outcomes:
measure: 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
timeFrame: 18 months
Other outcomes:
Locations:
city: Dabou
country: Côte D'Ivoire
facility: Hôpital Méthodiste de Dabou
city: Maluku Tengah
country: Indonesia
facility: Tulehu health center
state: Maluku
city: Maluku Tengah
country: Indonesia
facility: Tulehu hospital
state: Maluku
city: Bamako
country: Mali
facility: Institut National de Recherche en Santé Publique
city: Niono
country: Mali
facility: Niono District Reference Health Centre
city: Dhankuta
country: Nepal
facility: Dhankuta District Hospital
city: Dharan
country: Nepal
facility: B.P. Koirala Institute of Health Sciences
Study officials:
affiliation: Swiss Tropical & Public Health Institute
name: Jürg Utzinger, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Tropical Medicine, Belgium
name: Katja Polman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Tropical Medicine, Belgium
name: Marleen Boelaert, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.