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IRCT20220116053739N1 IRCT 2022-04-15 Shahre-kord University of Medical Sciences Evaluation of the clinical course and consequences of disease in the children suspicious to Covid-19 who have/have not received Antibiotics Evaluation of the clinical course and consequences of disease in the children suspicious to Covid-19 who have/have not received Antibiotics 2021-09-28 anticipated 70 Complete https://irct.ir/trial/61358 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants have been randomly distributed to the control and experimental groups using Random Allocation Software, Blinding description: In selecting the envelopes, neither the participant nor the researcher is not aware of the envelope content and an envelope is randomly selected for each patient. After selecting an envelope, the parents of the patient are informed if the patient had received Antibiotic or not. Even the researcher was not informed of that. The number of participants in the study was considered to be envelopes with numbers 1 to 70 and using the software, the number 0 or 1 was randomly assigned to each envelope, and the number zero means not receiving antibiotics and the number 1 It means taking antibiotics. 3 Covid-19. Intervention 1: Patients in the intervention group were treated with a group of antibiotics with gram-negative and gram-positive coverage (third generation cephalosporin). Third-generation cephalosporins include cefotaxime (from Eixir Pharmaceutical Company) as an injection at a dose of 50 mg per kg every 8 hours for at least 7 days. Also in this group, the routine hospital care intervention intended for the control group included serum therapy (including normal saline serum, one-third and two-thirds serum), and the use of antipyretics (acetaminophen at a dose of 10 mg per kg). It was administered orally or by injection in patients with a body temperature of more than 38 with an interval of at least 6 hours. Intervention 2: In the control group, patients did not receive any antibiotics and routine hospital care included serum therapy (including normal saline, one-third and two-thirds serum), and the use of antipyretics (acetaminophen at a dose of 10 mg per kg). Received orally or by injection in patients with a body temperature greater than 38 (at least 6 hours apart) during hospitalization. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After analyzing the results, a decision will be made on this issue
public Maryam Mohsenifar
Somaheh Blvd.
Shahrekord Iran (Islamic Republic of) 8814873588 0983833335833 amin_mohsenifar@outlook.com Shahre-kord University of Medical Sciences scientific Nabiollah Asadpour
Parastar Street
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3333 0061 n.asadpour@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) The patient with IgM positive The patient with confirmed molecular test 2 years 14 years Both Having the background of Underlying disease Any clinical or laboratory evidence of the patient need for Antibiotics Lack of consent of the patient and his/her family for the participation in the study U07.1 Covid 19 Treatment - Drugs Treatment - Drugs Patients in the intervention group were treated with a group of antibiotics with gram-negative and gram-positive coverage (third generation cephalosporin). Third-generation cephalosporins include cefotaxime (from Eixir Pharmaceutical Company) as an injection at a dose of 50 mg per kg every 8 hours for at least 7 days. Also in this group, the routine hospital care intervention intended for the control group included serum therapy (including normal saline serum, one-third and two-thirds serum), and the use of antipyretics (acetaminophen at a dose of 10 mg per kg). It was administered orally or by injection in patients with a body temperature of more than 38 with an interval of at least 6 hours. In the control group, patients did not receive any antibiotics and routine hospital care included serum therapy (including normal saline, one-third and two-thirds serum), and the use of antipyretics (acetaminophen at a dose of 10 mg per kg). Received orally or by injection in patients with a body temperature greater than 38 (at least 6 hours apart) during hospitalization. Duration of hospitalization. Timepoint: Time of discharge from the hospital. Method of measurement: Number of days hospitalized. Complete blood count (CBC). Timepoint: Day of hospitalization, seven days after hospitalization. Method of measurement: Use of cell counting machine. Fever. Timepoint: Day of hospitalization, seven days after hospitalization and One month after hospitalization. Method of measurement: Thermometer. Cough. Timepoint: Day of hospitalization, seven days after hospitalization and One month after hospitalization. Method of measurement: Asking the patient. Test result of Troponin. Timepoint: Day of hospitalization and seven days after hospitalization. Method of measurement: Troponin test kit. D-dimer. Timepoint: Day of hospitalization and seven days after hospitalization. Method of measurement: Latex agglutination test. Erythrocyte Sedimentation Rate (ESR). Timepoint: Day of hospitalization and seven days after hospitalization. Method of measurement: The Westergren method. C-reactive protein test (CRP). Timepoint: Day of hospitalization and seven days after hospitalization. Method of measurement: Latex agglutination test. Anorexia. Timepoint: Day of hospitalization, seven days after hospitalization and One month after hospitalization. Method of measurement: Asking the patient. Shahrekord University Medical Science Approved 2021-09-28 Ethics Committee of Shahrekord University of Medical Sciences somaheh Blvd. shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)