Phase II Randomized Clinical Trial of quinacrine versus metronidazole in resistant giardiasis in children: Quin4Kids
Phase 1
- Conditions
- Intestinal giardiasisTherapeutic area: Diseases [C] - Parasitic Diseases [C03]
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Children aged 1 to 18 years of age., Diagnosed with intestinal giardiasis., Informed consent/assent., Refractory to first line treatment
Exclusion Criteria
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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 Objective: 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.;Primary end point(s): Proportion of participants achieving microbiological eradication of Giardia intestinalis in each study arm.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Plasma drug concentration at the different time-points (Pharmacokinetic data).;Secondary end point(s):Hair drug concentration at the different time-points (Pharmacokinetic data).;Secondary end point(s):Proportion of patients with any adverse event.;Secondary end point(s):Proportion of drug discontinuation due to adverse effects. Tolerability.;Secondary end point(s):Proportion of strains carrying gene mutations related with metronidazole resistance.;Secondary end point(s):Proportion of co-parasitation.;Secondary end point(s):To generate pharmacokinetic data for the development of a specific pediatric galenic formulation.;Secondary end point(s):To obtain a cohort of resistant giardia isolates for further genetic characterization and/or cluster study.;Secondary end point(s):To characterize the cohort of pediatric patients harbouring resistant strains.