The Efficacy and Safety of Hydrochlorothiazide as an Adjunct Therapy for Clearing Urinary Tract Infections in Children

Determination of the safety and efficacy of Hydrochlorothiazide as an adjuvant therapy for Pediatric urinary tract infection

A Phase 2, randomized, parallel-group, open-label, controlled clinical trial involving 74 patients, with randomization performed using the Excel rand function.

Following the acquisition of informed consent from parents, tests will be performed on patients presenting to the inpatient and outpatient departments of Amirkabir Hospital in Arak and lab results and checklists will be kept confidential. Patients will be randomly assigned using a permutation based method to the intervention or control group and will undergo the intended intervention. Tests will be Repeated ten days after the start of treatment and Lab results and checklist information will be collected confidentially by the study investigator. This study will not involve blinding.

The inclusion criteria for this study are an age range of 1 to 18 years and the presence of a urinary tract infection. Patients with anatomical abnormalities of the urinary system such as labial adhesions, renal dysfunction, neurogenic bladder, or voiding disorders will be excluded from the study.

Control group: They receive antibiotic therapy as prescribed by the attending pediatrician without hydrochlorothiazide for 7 days. Intervention group: They receive antibiotic therapy as prescribed by the attending pediatrician plus Hydrochlorothiazide 25 mg tablets at a dosage of 0.5 mg/kg administered as a single daily dose (maximum 100 mg/day) for 7 days.

Primary outcome: Eradication of urinary tract infection; secondary outcomes: fever, urinary frequency, urinary dribbling, dysuria, urinary urgency, urinary incontinence, abdominal pain, Malaise, irritability, drug safety, and drug efficacy

In this Randomized Clinical Trial, Participants will be allocated to the Intervention and Control Groups in a 1:1 Ratio using Permuted Block Randomization with a Block Size of Six after Enrollment into the Study. The Unit of Randomization is the Individual Participant. Stratified Randomization will not be used. The Randomization Sequence will be generated Prior to the Initiation of the Study using Statistical Software. Participants will be assigned to the Study Groups According to the Generated Randomization Sequence by the Supervising Investigator. No Specific Allocation Concealment Method will be implemented in this Study.

The results examined in the study—such as blood and urine test findings and items covered in checklists—will be shareable after the study participants have been de-identified.

Data from the study will be available for up to six months after the publication of the results.

Data derived from the study will be available to researchers affiliated with academic and scientific institutions.

Researchers affiliated with academic and scientific institutions can utilize the data and results of this study for citation purposes and to conduct further research.

To obtain the data and documentation resulting from this study, please contact the project lead via email at arshiakhalili3@gmail.com

The applicant must contact the project executor via email, and the results will be sent within one week. arshiakhalili3@gmail.com