Clinical trial • Phase II • Infectious Disease

MEPACRINE for Intestinal giardiasis

Phase II trial of MEPACRINE for Intestinal giardiasis.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Intestinal giardiasis
Trial Stage
Phase II
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
23-02-2024
First CTIS Authorization Date
05-06-2024

Trial design

Randomised, open-label, metronidazole; 40mg/kg/day every 8h x 10 days. route of administration: oral-controlled Phase II trial in Spain.

Randomised
Yes
Open Label
Yes
Comparator
Metronidazole; 40mg/kg/day every 8h x 10 days. Route of administration: Oral
Target Sample Size
48

Eligibility

Recruits 48 paediatric patients.

Pregnancy Exclusion
Pregnant woman.
Vulnerable Population
Children aged 1 to 18 years; 'Informed consent/assent.'

Inclusion criteria

  • {"criterion_text":"- Children aged 1 to 18 years of age.\n- Diagnosed with intestinal giardiasis.\n- Informed consent/assent.\n- Refractory to first line treatment"}

Exclusion criteria

  • {"criterion_text":"- History of allergy or previous positive skin-test reaction to any of the drug compounds included.\n- Liver disease and/or liver enzymes > x3.\n- Pregnant woman.\n- Oral intolerance."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of participants achieving microbiological eradication of Giardia intestinalis in each study arm.","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Plasma drug concentration at the different time-points (Pharmacokinetic data).","definition_or_measurement_approach":"Plasma drug concentration measured at specified time-points (pharmacokinetic sampling)."}
  • {"endpoint_text":"- Hair drug concentration at the different time-points (Pharmacokinetic data).","definition_or_measurement_approach":"Hair drug concentration measured at specified time-points (pharmacokinetic sampling)."}
  • {"endpoint_text":"- Proportion of patients with any adverse event.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Proportion of drug discontinuation due to adverse effects. Tolerability.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Proportion of strains carrying gene mutations related with metronidazole resistance.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Proportion of co-parasitation.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- To generate pharmacokinetic data for the development of a specific pediatric galenic formulation.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- To obtain a cohort of resistant giardia isolates for further genetic characterization and/or cluster study.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- To characterize the cohort of pediatric patients harbouring resistant strains.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
48
Recruitment Window Months
48
Consent Approach
Informed consent/assent.

Geography

Total Number Of Sites
5
Total Number Of Participants
48

Spain

Earliest CTIS Part Ii Submission Date
28-05-2024
Latest Decision Or Authorization Date
05-06-2024
Processing Time Days
8
Number Of Sites
5
Number Of Participants
48

Sites

Site Name
Sant Joan De Deu Barcelona Hospital
Department Name
Infectious Service
Contact Person Name
Victoria Fumadó
Contact Person Email
victoria.fumado@sjd.es
Site Name
Hospital Universitario La Paz
Department Name
Hospital Pediatrics Service, Diseases Infectious and Tropical
Contact Person Name
Talía Sainz Costa
Contact Person Email
tsainzcosta@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Pediatric Infectology
Contact Person Name
Begoña Carazo Gallego
Contact Person Email
bcarazo002@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Pediatric Infectious Diseases Unit, Pediatric Service
Contact Person Name
Begoña Santiago García
Contact Person Email
bsantiagogarcia@gmail.com
Site Name
Vall D'hebron Institut De Recerca
Department Name
Infectious Pathology and Immunodeficiencies Unit pediatric
Contact Person Name
María Espiau Guarner
Contact Person Email
mariaespiau@hotmail.com

Sponsor

Primary sponsor

Full Name
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Organisation Type
Patient organisation/association
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
MEPACRINE 100 MG
Active Substance
MEPACRINE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Starting Dose
2 mg/kg every 8 hours for 5 days.
Dose Levels
2 mg/kg every 8 hours for 5 days.
Frequency
Every 8 hours
Investigational Product Name
MEPACRINE 5 MG CAPSULES
Active Substance
MEPACRINE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Starting Dose
2 mg/kg every 8 hours for 5 days.
Dose Levels
2 mg/kg every 8 hours for 5 days.
Frequency
Every 8 hours
Investigational Product Name
MEPACRINE 25 MG CAPSULES
Active Substance
MEPACRINE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Starting Dose
2 mg/kg every 8 hours for 5 days.
Dose Levels
2 mg/kg every 8 hours for 5 days.
Frequency
Every 8 hours
Investigational Product Name
Metronidazol NORMON 250 mg comprimidos EFG
Active Substance
METRONIDAZOLE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Starting Dose
40 mg/kg/day every 8 hours for 10 days.
Dose Levels
40 mg/kg/day every 8 hours for 10 days.
Frequency
Every 8 hours

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