Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Authorised, recruitment pending
Participants planned
48
Countries
1
Sites
5
Intestinal giardiasis
To demonstrate the safety and non-inferior anti-giardia activity of oral quinacrine (QC) 6mg/kg/day administered every 8h for a period of 5 days compared to standard therapy (metronizadole high doses) in resistant intestinal giardiasis in children aged 1 to 18 years of age.
Key facts
- Sponsor
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Parasitic Diseases [C03]
- Decision date (initial)
- 2024-06-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To demonstrate the safety and non-inferior anti-giardia activity of oral quinacrine (QC) 6mg/kg/day administered every 8h for a period of 5 days compared to standard therapy (metronizadole high doses) in resistant intestinal giardiasis in children aged 1 to 18 years of age.
Secondary objectives 5
- To describe the pharmacokinetics of oral quinacrine (QC) in children.
- To define the relationship between drug exposure (pharmacokinetics) and efficacy and tolerability.
- To evaluate tolerability.
- To characterize determinants of treatment failure (co-parasitation, parasitic load, resistance mutations).
- To evaluate acceptability to drug treatment.
Conditions and MedDRA coding
Intestinal giardiasis
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase II, open-label, randomized, multicentre clinical trial. Randomized, non-blinded, phase II clinical trial, whose main objective is to determine the safety and non-inferiority of quinacrine as treatment in refractory Giardia intestinalis parasitation in children, and to generate pharmacokinetic data.
|
Randomised Controlled | None | Experimental treatment: Quinacrine; 2mg/kg/8h. 5 days. Route of administration: Oral Comparator: Metronidazole; 40mg/kg/day every 8h x 10 days. Route of administration: Oral |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Children aged 1 to 18 years of age.
- Diagnosed with intestinal giardiasis.
- Informed consent/assent.
- Refractory to first line treatment
Exclusion criteria 4
- History of allergy or previous positive skin-test reaction to any of the drug compounds included.
- Liver disease and/or liver enzymes > x3.
- Pregnant woman.
- Oral intolerance.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of participants achieving microbiological eradication of Giardia intestinalis in each study arm.
Secondary endpoints 9
- Plasma drug concentration at the different time-points (Pharmacokinetic data).
- Hair drug concentration at the different time-points (Pharmacokinetic data).
- Proportion of patients with any adverse event.
- Proportion of drug discontinuation due to adverse effects. Tolerability.
- Proportion of strains carrying gene mutations related with metronidazole resistance.
- Proportion of co-parasitation.
- To generate pharmacokinetic data for the development of a specific pediatric galenic formulation.
- To obtain a cohort of resistant giardia isolates for further genetic characterization and/or cluster study.
- To characterize the cohort of pediatric patients harbouring resistant strains.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD11131112 · Product
- Active substance
- Mepacrine
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- ATC code
- P01AX05 — MEPACRINE
- MA holder
- FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DEL HOSPITAL UNIVERSITARIO DE LA PAZ (FIBHULP)
- Paediatric formulation
- No
- Orphan designation
- No
PRD11131217 · Product
- Active substance
- Mepacrine
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- ATC code
- P01AX05 — MEPACRINE
- MA holder
- FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DEL HOSPITAL UNIVERSITARIO DE LA PAZ (FIBHULP)
- Paediatric formulation
- No
- Orphan designation
- No
PRD11010051 · Product
- Active substance
- Mepacrine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- ATC code
- P01AX05 — MEPACRINE
- MA holder
- FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DEL HOSPITAL UNIVERSITARIO DE LA PAZ (FIBHULP)
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
Metronidazol NORMON 250 mg comprimidos EFG
PRD370739 · Product
- Active substance
- Metronidazole
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- P01AB01 — METRONIDAZOLE
- Marketing authorisation
- 62.223
- MA holder
- LABORATORIOS NORMON, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
- Sponsor organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
- Address
- Paseo Castellana 261
- City
- Madrid
- Postcode
- 28046
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
- Contact name
- Talía Sainz Costa
Public contact point
- Organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
- Contact name
- Talía Sainz Costa
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 48 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario La Paz
Hospital Pediatrics Service, Diseases Infectious and Tropical, Paseo Castellana 261, 28046, Madrid
Sant Joan De Deu Barcelona Hospital
Infectious Service, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Hospital General Universitario Gregorio Maranon
Pediatric Infectious Diseases Unit, Pediatric Service, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Regional De Malaga
Pediatric Infectology, Avenida De Carlos De Haya Sn, 29010, Malaga
Vall D'hebron Institut De Recerca
Infectious Pathology and Immunodeficiencies Unit pediatric, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocolo QUIN4KIDS_Final_redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | FT_Metronidazol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Mepacrine 100 mg Ascot Lab | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis _QUIN4KIDS_2023-510227-30-00_redacted | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-23 | Spain | Acceptable with conditions 2024-06-03
|
2024-06-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-17 | Spain | Not acceptable 2025-12-09
|
2025-12-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-28 | Spain | Acceptable 2026-03-16
|
2026-03-17 |