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IRCT20231111060021N1 IRCT 2023-11-26 Mashhad University of Medical Sciences Investigating the effect of topical ketoconazole in preventing fungal peritonitis in children undergoing peritoneal dialysis Investigating the effect of topical ketoconazole in preventing fungal peritonitis in children undergoing peritoneal dialysis 2023-09-23 anticipated 40 Complete https://irct.ir/trial/73724 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention. 2-3 Child– Ketoconazole – Fungal Peritonitis – Chronic Peritoneal Dialysis.. Control group: Control group(s) (placebo, no placebo):The control group is the same group that did not receive prophylaxis in the last year. Yes - There is a plan to make this available What will be shared: Various methods have been recommended to prevent catheter exit infection, including catheter site care methods and prophylaxis with local antibiotics, but the use of antifungal drugs is not common. (2, 3). Ketoconazole is an antifungal drug that has been used since 1981 in the clinic. This drug prevents the growth and reproduction of fungi by inhibiting the synthesis of fungal ergosterol. The spectrum of effects of ketoconazole in systemic use includes Candida species (except C. glabrata), Malassezia and skin dermatophytes (4, 5). Due to the extensive side effects of ketoconazole including hepatotoxicity, adrenal disorders, and important drug interactions (through inhibition of the CYP450 3A4 enzyme), the use of this drug in the clinic is currently limited to cases where other antifungal drugs cannot be prescribed (6). Topical ketoconazole is effective against skin fungal infections and systemic side effects are not observed.The topical medicinal forms of ketoconazole include 1% and 2% shampoo, cream, foam and 2% gel, of which the common medicinal form in Iran is 2% shampoo. When: During one year, the patients randomly receive prophylaxis using ketoconazole weekly and topically on the abdominal skin, which is by washing with 2% ketoconazole shampoo. The shampoo brand is Iran Najo, and the cost of the shampoo is 12,000 Tomans, which is given from the Pezohashi grant. And culture of peritoneal return fluid in terms of fungi and bacteria is taken from the patients before starting shampoo and then after three months and after 6 months. If there are clinical symptoms of peritonitis, turbidity of peritoneal return fluid, abdominal pain, fever, immediately culture and smear of return peritoneal fluid in terms of fungus and bacteria is sent. Will be During this period, there is prophylaxis with mupirocin for all patients, which is part of the standard prophylaxis treatment of Verotin.The control group of these patients is the same group before using 2% ketoconazole shampoo. Informed consent is obtained from the legal guardian of the patients. Ketoconazole shampoo side effects include skin irritation and itching, oily or dry skin, abnormal hair texture or hair discoloration. Rarely possible. Does this drug cause hair loss. Allergic reactions to ketoconazole are very rare, but should be taken seriously. In case of allergic symptoms such as severe itching and swelling in the face, tongue or throat, shortness of breath and skin rashes, dizziness, stop using shampoo and the patient will be excluded from the study. To whom: All children undergoing dialysis at Dr. Sheikh's peritoneal clinic who meet the inclusion criteria and are between the ages of 6 and 18 will be included in the study after obtaining informed consent.Peritoneal Dialysis Department of Dr. Sheikh Hospital. Conditions: Criteria for entering the study: Age 6 years to 18 years Receiving peritoneal dialysis Absence of underlying skin diseases based on initial clinical evaluation Not having fungal peritonitis Informed consent Where to obtain: Peritoneal Dialysis Department of Dr. Sheikh Hospital How to obtain: The time required to reach this sample size: 12 months Intervention / exposure / main outcome group: Patients in an intervention group will receive non-random ketoconazole prophylaxis weekly using 2% ketoconazole shampoo, smear and culture of peritoneal return fluid for fungi and bacteria before startingTaken shampoo and after three months and after 6 months from the patients. Comments:
public Sara Saadat
Dr. Sheikh Children's Hospital, Dr. Sheikh Street, Tohid Sq.
Mashhad Iran (Islamic Republic of) 9177857984 +98 51 3726 9021 SaadatS@mums.ac.ir Mashhad University of Medical Sciences scientific Sara Saadat
Dr.Sheikh Hospital
Mashhad Iran (Islamic Republic of) 9177857984 +98 51 3726 9021 SaadatS@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Children undergoing peritoneal dialysis Absence of underlying skin diseases based on initial clinical evaluation Not have fungal peritonitis Informed consent Age 6 to 18 years 6 years 18 years Both Diffuse infection requires receiving broad_spectrum antibiotics Having an open wound at the exit site of the catheter Need to change the catheter Incidence of skin sensitivity with topical ketoconazole Diagnosis Control group: Control group(s) (placebo, no placebo):The control group is the same group that did not receive prophylaxis in the last year Evaluating the effectiveness of topical use of 2% ketoconazole shampoo in preventing fungal peritonitis in children with peritoneal dialysis. Timepoint: Smear and culture of peritoneal fluid for fungi and bacteria are taken from patients before shampooing and after three months and after six months. Method of measurement: Returned peritoneal fluid culture and smear. Mashhad University of Medical Sciences Approved 2023-08-28 e.g. Ethics committee of Mashhad University of Medical Sciences Faculty of Medicine, Mashhad University of Medical Sciences, Kalantari Highway., Town Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)