Clinical Prognostic Score to Predict Relapse in VL

NCT05602610 | Recruiting

• 1 other identifier: 1544/21
• Study Type: observational
• Target: 741
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective cohort study has the aim to develop a prognostic tool to predict relapse in patients suffering from visceral leishmaniasis (VL) from VL endemic regions in Ethiopia. Therefore, comprehensive clinical and laboratory characterization of all confirmed VL patients before and during treatment will be performed in order to identify the factors that determine prognosis of the patients. This approach would result in more efficient patient care and would reduce the case fatality and morbidity, and improve follow-up and care for those at risk of VL relapse.

Conditions

Visceral Leishmaniasis

Keywords

leishmaniasis; visceral; neglected; relapse; Ethiopia

Outcome Measures

Primary Outcomes (2)

• Identification of risk factors for relapse

  The association between development of relapse and potential risk factors (demographic/clinical characteristics as well as host immunity/Leishmania infection markers)

  December 2026

• Prognostic tool for relapse

  A clinical decision algorithm, prioritizing and integrating identified risk factors, that is able to most efficiently predict the risk of developing relapse within 12 months after start of treatment

  December 2026

Secondary Outcomes (3)

• Patterns in host immune markers for VL relapse, treatment failure and death

  December 2026

• Identification of risk factors for treatment failure

  December 2026

• Identification of risk factors for death

  December 2026

Study Arms (1)

VL patients

VL infected individuals residing in/ with travel history to VL-endemic areas in Northern Ethiopia

Other: No intervention

Interventions

No intervention OTHER

No intervention

VL patients

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with clinically or parasitologically confirmed VL in Northern Ethiopia

You may qualify if:

• clinically or parasitologically confirmed VL

You may not qualify if:

• Age under 12 years
• VL patients already on treatment for 3 days or more
• Severe critical condition or other circumstances that make the study medically inadvisable
• Unlikely to adhere to follow up visits during the study period (e.g. patients who live or work very far away) AND not reachable by phone for follow-up information
• Pregnant or lactating woman

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• University of Gondar: collaborator

Study Sites (1)

University of Gondar

Gonder, Ethiopia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, tissue, sputum

MeSH Terms

Conditions

Leishmaniasis, Visceral; Leishmaniasis; Recurrence

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saskia van Henten, MD

  Institute of Tropical Medicine Antwerp, Antwerp, Belgium

  STUDY CHAIR

• Eleni Ayele, MD

  University of Gondar, Gondar, Ethiopia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saskia van Henten, MD

CONTACT

+32(0)32476556; svanhenten@itg.be

Study Design

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

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 2, 2022
• Study Start: February 3, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

ET (1)