Phase II Randomized Clinical Trial of quinacrine versus metronidazole in resistant giardiasis in children: Quin4Kids

Conditions

Intestinal giardiasis

Brief summary

Proportion of participants achieving microbiological eradication of Giardia intestinalis in each study arm.

Detailed description

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.

Related papers

No related papers found yet.

Papers published before 2002-11-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGMEPACRINE 5 MG CAPSULES

DRUGMEPACRINE 100 MG

DRUGMEPACRINE 25 MG CAPSULES

DRUGMetronidazol NORMON 250 mg comprimidos EFG

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Proportion of participants achieving microbiological eradication of Giardia intestinalis in each study arm.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Spain

Outcome results

None listed