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Study aim
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1-Determination of the effect of amikacin on two-day intervals on ESBL E.coli in the intervention group
2. Determine the effect of standard treatment on ESBL E.coli in the control group
3. Determination of the effect of amikacin on two-day intervals on non ESBL Ecoli in the intervention group
4- Determination of the effect of Standard on non ESBL Ecoli in the control group
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Design
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People who come to the Tohid Hospital with burning symptoms, frequencies, or fever undergo a smear test and urine analysis and culture. And the names of all of them are recorded. After the patient has been diagnosed with urinary tract infections and confirmed by an infectious disease physician, the patient is included in the study. Individuals who entered the randomly-assigned blocks with 20 blocks in one of the two new treatment groups and the two control groups Usually). Considering that at the beginning of the study urine sample should be cultured and after the culture, the group should be identified, but based on ethical principles, patients can not be left without treatment during the first few days, therefore, from the beginning, randomization is done and after The result of the cure will continue treatment in the same group. Therefore, considering that about 64% of ESBL (Expended expectrum beta lactamases) patients are positive, therefore, for access to 50 patients in each group, 160 patients need to be examined in order to finally receive a 50-member ESBL positive group in each intervention group and 30 patients In each group, ESBL will remain negative, and each will receive one kind of intervention. But the main goal of the study is to compare the two groups of 50. To compensate for possible dropouts, 200 people will be examined. After group treatment, protocol treatment is given to each group (one group of meropenem and one group of amikacin). The drug is prescribed by microset. The new treatment will receive 3mg / kg of amikacin every 48 hours and the control group will receive 1gr / TDS of meropenem every 8 hours. Blind for each group is injected through the microset at intervals of 8 hours, in the intervention group, additional injections contain distilled water, which is poured into normal saline containing microset. Medicines are placed in the patient basket by category. And the nurse will run the daily basket in accordance with its instructions. Given that the assessor, the laboratory, and the patient are unaware of any grouping, the study is virtually double blind.
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Settings and conduct
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After determining the treatment group, the treatment is given to each group based on the protocol (one group of meropenem and one group of amikacin). The drug is administered via microset. The new treatment group receives amikacin at 3mg / kg / Q48 hours. The control group receives 1 μg / TDS of meropenem every 8 hours. Blind for each group is injected through the microset at intervals of 8 hours, in the intervention group, additional injections contain distilled water, which is poured into normal saline containing microset. Medicines are placed in the patient basket by category. And the nurse will run the daily basket in accordance with its instructions. Given that the assessor, the laboratory, and the patient are unaware of any grouping, the study is virtually double blind.
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Participants/Inclusion and exclusion criteria
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Entry criteria: Patients with signs of burning and frequent urination or fever
Exit criteria: 1.use of antibiotics over the last week 2. Patients at stage I and above CKD(chronic kidney diseases) 3.pregnancy 4.septic shock 5.use of immuno suppressive drugs 6.Increased patient creatinine by more than 3 or more than 50% relative to the original creatinine during treatment
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Intervention groups
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1.ESBL intervention (50 people):In a group of patients who are ESBL-positive Each 48 hours of amikacin is given 3mg / kg for 7 days and then treatment of 300 mg of ofloxacin twice daily for 7 days. At the end of the initial initial injection, clinical symptoms are recorded and urine analysis and culture tests are performed.
2. Non-ESBL intervention (30 people):In a group of patients who are non-ESBL-positive Each 48 hours of amikacin is given at 3mg / kg for 7 days. Then the treatment with ofloxacin 300 mg twice daily for 7 days is continued. At the end of the initial initial injection, clinical symptoms are recorded and a urine analysis and culture test is performed.
3. ESBL control (50 peaple): INn ESBL control group patients Meropenem is given at a dose of 1 g three times a day for one week, followed by treatment with ofloxacin 300 mg twice daily for 7 days.
4. NON ESBL control (30 peaple): In non-ESBL control group patients Meropenem is given at a dose of 1 g three times a day for one week, followed by treatment with ofloxacin 300 mg twice daily for 7 days.
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Main outcome variables
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Treatment of urinary tract infection in patients with positive culture of E. coli during admission