Evaluating and comparison study of effect of ceftriaxone versus ciprofloxacin treatment on dysentery in children referred to Taleghani Children's Hospital in Gorgan
Comparison of the effects of ceftriaxone and ciprofloxacin in the treatment of acute bloody diarrhea in children.
Design
Clinical trial with two intervention groups, with parallel groups, double blind strain (patients, researcher), randomized, phase 2-3 on 196 patients, rand function of Excel software was used for randomization.
Settings and conduct
This study is an interventional, randomized, parallel, double-blind (patient and evaluator) clinical trial on children aged 2-15 who presented with complaints of acute bloody diarrhea. Patients will be randomized into one of two study groups (first group: intravenous ceftriaxone at a dose of 50 mg/kg daily until the third day/ second group: intravenous ciprofloxacin at a dose of 10 mg/kg twice a day until three days). On the third day, patients who have a reduction in symptoms and improvement in general condition and a negative stool culture will be considered as a suitable treatment response. Finally, the two groups will be compared with each other.
Participants/Inclusion and exclusion criteria
All children with acute bloody diarrhea aged 2 to 15 years, with no history of antibiotic uses in the last week and having sensitivity to two drugs ceftriaxone and ciprofloxacin in the initial antibiogram
Intervention groups
First group: treated with intravenous ceftriaxone / second group: treated with intravenous ciprofloxacin
Main outcome variables
The symptoms of diarrhea, negative culture and reducing the duration of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231119060110N1
Registration date:2024-04-10, 1403/01/22
Registration timing:retrospective
Last update:2024-04-10, 1403/01/22
Update count:0
Registration date
2024-04-10, 1403/01/22
Registrant information
Name
shafighe taneh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3442 6857
Email address
shafighetaneh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-01, 1402/09/10
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating and comparison study of effect of ceftriaxone versus ciprofloxacin treatment on dysentery in children referred to Taleghani Children's Hospital in Gorgan
Public title
Comparison study of effect of ceftriaxone versus ciprofloxacin treatment on dysentery in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not receiving antibiotics during the last week
Consent to participate in the study
Sensitivity to both ceftriaxone and ciprofloxacin in the initial antibiogram
Exclusion criteria:
Any sensitivity to fluoroquinolones and cephalosporins
Immune deficiency disease and malnutrition in children
No follow up and Low drug compliance of the patient in the 5-day period of treatment
Age
From 2 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
196
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to experimental and control groups using the random block method. To perform randomization using quadruple blocks, first by throwing 16 regular hexagons 16 times, a random sequence of 16 quadruple blocks will be generated from the following blocks: AABB-ABAB-ABBA-BAAB-BABA-BBAA In the sequence, there will be 32 of each letter A and B. According to the above block, 64 envelopes will be prepared and in each envelope, the letter A or B will be placed and will be numbered from 1 to 64. The person delivering the envelopes to the patients does not know the letters inside. Randomization is done by a statistics and methodology consultant who does not have access to patients and only he knows what is in each envelope. Patients who received the letter A will be in the Ceftriaxon group and patients who received the letter B will be in the Ciprofloxacin group.
Blinding (investigator's opinion)
Double blinded
Blinding description
After assigning the patients randomly, two groups of patients will use the same medicine with the same packaging and they will not know the type of treatment received.The researcher who evaluates the symptoms and recovery of the patients also does not know the type of treatment received by the patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of golestan University of Medical Sciences
Street address
At the beginning of Shast Kola Road, Hyrkan Boulevard, Basij Square
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2023-11-18, 1402/08/27
Ethics committee reference number
IR.Goums.REC.1402.369
Health conditions studied
1
Description of health condition studied
Acute hemorrhagic gastroenteritis
ICD-10 code
A09
ICD-10 code description
Infectious gastroenteritis and colitis, unspecified
Primary outcomes
1
Description
Acute bloody diarrhea frequency and severity
Timepoint
3 days and 5 days after the start of treatment
Method of measurement
By asking the patient and parents
Secondary outcomes
1
Description
Cease of fever
Timepoint
Before the start of the intervention, the 3rd and 5th day of the study
Method of measurement
By checking vital signs and stool culture
2
Description
Stool cultures becoming negative on the 3rd day of starting treatment.
Timepoint
Before the start of the intervention, the 3rd and 5th day of the study
Method of measurement
By checking vital signs and stool culture
3
Description
Duration of symptom reduction (reduction of diarrhea frequency)
Timepoint
Before the start of the intervention, the 3rd and 5th day of the study
Method of measurement
By checking vital signs and stool culture
4
Description
Duration of symptom reduction( reduction of blood and mucus in stool )
Timepoint
Before the start of the intervention, the 3rd and 5th day of the study
Method of measurement
By checking vital signs and stool culture
5
Description
Duration of symptom reduction( recovery in general condition)
Timepoint
Before the start of the intervention, the 3rd and 5th day of the study
Method of measurement
By checking vital signs and stool culture
Intervention groups
1
Description
Intervention group: treated with intravenous ceftriaxone treated with intravenous ceftriaxone at a dose of 50 mg/kg daily until the third day
Category
Treatment - Drugs
2
Description
Intervention group: treated with intravenous ciprofloxacin at a dose of 10 mg/kg/twice a day for three days
What processes are involved for a request to access data/document
The applicant should provide a description of her study and the purpose of receiving the data in an email format along with her research file (research plan), then after a period of 3 months, the file will be provided to the individual