]>
IRCT20201015049030N2 IRCT 2022-04-12 Tehran University of Medical Sciences Comparison of the efficacy and possible side effects of high and standard doses of rifampin in the treatment of brucellosis Comparison of the efficacy and possible side effects of high and standard doses of rifampin in the treatment of brucellosis, a randomized clinical trial 2022-04-04 anticipated 55 Complete https://irct.ir/trial/62738 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Restricted randomization method will use block randomization method. Blocking will be used primarily to balance the number of samples allocated in each of the study groups. This has helped the researcher to ensure that in cases where intermediate surveys are needed during sampling, the number of samples allocated to each of the study groups will be equal. The size of all blocks is equal. In this experiment, two groups of 6 blocks (including 3 participants in the intervention group and 3 participants in the control group) will be used. Randomization tools will also be used based on software random allocation software. In order to generate a random sequence, these softwares are able to generate a random sequence by blocking method in addition to simple randomization. For concealment, the concealment allocation method will be used to execute a random sequence on the participants in a way that the assigned group is not known before the individual is assigned. In this method, using envelopes that were opaque sealed, random sequences (envelopes opaque, sealed, numbered sequentially) were recorded on a card and the drugs were placed in the envelopes, respectively. In order to maintain a random sequence, it was necessary to number the envelopes on the outer surface so that the numbering would be done in the same way. Finally, the letter envelopes were sealed and placed inside a box. At the beginning of the intervention and according to the order of entry of the subjects who were eligible to study, one of the envelopes will be opened in order in the group assigned to that participant. , Will be revealed, Blinding description: After selecting the samples, none of the participants will be aware of randomization and assignment to groups. Physicians are given a table of pre-coded numbered numbers, and patients are entered into the study in tabular order. Three smaller envelopes will be placed in the envelopes, Containing small envelopes for the intervention group 1- Doxycycline is 100 mg q 12. On this envelope, this sentence is written. This capsule should be taken one morning, two hours after breakfast, and one evening, one hour before dinner, with plenty of water. Do not lie down for an hour after consumption. 2- The second pack contains 600 mg / day of rifampin. This sentence is written on this envelope. Take two Rifampin 300 mg capsules every morning on an empty stomach and do not eat breakfast for an hour. 3- The second pack contains 900-100 mg / day of yampin. On this envelope is written the sentence immediately before bedtime - one capsule in patients weighing 60 kg or less and two capsules in patients weighing more than 60 kg. Containing small envelopes for the control group 1- Doxycycline is 100 mg q 12. On this envelope, this sentence is written. This capsule should be taken one morning, two hours after breakfast, and one evening, one hour before dinner, with plenty of water. Do not lie down for an hour after consumption. 2- The second pack contains 600 mg / day of rifampin. It is written on this envelope that he should take two Rifampin 300 mg capsules every morning on an empty stomach and not eat breakfast for an hour. 3- The third envelope contains a placebo. On this envelope, it is written that this capsule should be taken at night immediately before going to bed (in case of weight of 60 kg or less, one capsule should be taken and weight of more than 60 kg should be taken in two capsules). Therefore, the present study will be double-blind. The envelope will contain the tablets in one shape, color and size and will be delivered to the patient in the package. N/A brucellosis. Intervention 1: Intervention group: Doxycycline treatment 100 mg q 12h + rifampin 900-1200 mg / dayIn this group, the patient is instructed to take two rifampin 300 mg capsules every morning on an empty stomach and not to eat breakfast for an hour.The next dose of rifampin at night immediately before bedtime,For patients weighing 60 kg or less, one 300 mg rifampin capsule- For patients weighing more than 60 kg, two rifampin capsules are 300 mg.In each group, patients are instructed to take 100 mg doxycycline capsules one in the morning, two hours after breakfast, and one in the evening, one hour before dinner with plenty of water, and up to one hour after Do not take doxycycline for a long time.Doxycycline is given in high doses with rifampin in the first four weeks and doxycycline in standard doses in the next four weeks. Intervention 2: Control group: Doxycycline treatment 100 mg q 12 h + rifampin 600 mg / day In this group, the patient is instructed to take two capsules of rifampin 300 mg every morning on an empty stomach and not to eat breakfast for an hour. Treated for eight weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Mohammad Reza Salehi
Keshavarz Blvd‎
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2811 salehi.mohamad3@gmail.com Tehran University of Medical Sciences scientific Mohammad Reza Salehi
Keshavarz Blvd‎
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2811 salehi.mohamad3@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Isolation of Brucella in culture of blood or bone marrow or other body fluids Positive Brucella PCR test in blood and / or body fluids or tissue samples Wright title equal to or greater than 160/1 The title of Combs Wright is at least two levels higher than Wright 14 years no limit Both Age less than 14 years- Intrinsic or acquired immunodeficiency Simultaneous with advanced or chronic heart, lung, liver and kidney diseases Pregnancy- Taking oral contraceptives Consumption of phenytoin History of receiving anti-brucellosis treatment in a recent month for more than a week Infection with local forms of malaria, endocarditis, spondylitis, meningitis, etc. Taking antibiotics more than 7 days before the visit History of allergy to doxycycline or rifampin General malaise so that the patient is not able to take medication orally. A23 Brucellosis Treatment - Drugs Treatment - Drugs Intervention group: Doxycycline treatment 100 mg q 12h + rifampin 900-1200 mg / dayIn this group, the patient is instructed to take two rifampin 300 mg capsules every morning on an empty stomach and not to eat breakfast for an hour.The next dose of rifampin at night immediately before bedtime,For patients weighing 60 kg or less, one 300 mg rifampin capsule- For patients weighing more than 60 kg, two rifampin capsules are 300 mg.In each group, patients are instructed to take 100 mg doxycycline capsules one in the morning, two hours after breakfast, and one in the evening, one hour before dinner with plenty of water, and up to one hour after Do not take doxycycline for a long time.Doxycycline is given in high doses with rifampin in the first four weeks and doxycycline in standard doses in the next four weeks. Control group: Doxycycline treatment 100 mg q 12 h + rifampin 600 mg / day In this group, the patient is instructed to take two capsules of rifampin 300 mg every morning on an empty stomach and not to eat breakfast for an hour. Treated for eight weeks. Response to treatment. Timepoint: The second, fourth, sixth and eighth weeks after starting treatment and up to three months after treatment. Method of measurement: Patients are divided into the following three groups in terms of response to treatment:1- Complete recovery: Complete recovery is considered when the symptoms disappear with treatment and by the end of the follow-up dose, the symptoms do not return and clinical signs are not found in favor of brucellosis.Relapse: It is when the symptoms have disappeared with treatment, but in the one-year follow-up period after the end of treatment, the symptoms have returned.3 - persistence of infection or treatment failure: is when the signs and symptoms of the disease at the end of treatment are still present. Side effects. Timepoint: The second, fourth, sixth and eighth weeks after starting treatment and up to three months after treatment. Method of measurement: Presence or absence of side effects. Wright laboratory test. Timepoint: The second, fourth, sixth and eighth weeks after starting treatment and up to three months after treatment. Method of measurement: Based on the results of the Wright laboratory test. Coombs test. Timepoint: The second, fourth, sixth and eighth weeks after starting treatment and up to three months after treatment. Method of measurement: Based on the results of the Coombs laboratory test. Tehran University of Medical Sciences Approved 2020-01-01 Ethics Committee of Imam Khomeini Hospital Complex Keshavarz Blvd‎ Tehran Tehran Iran (Islamic Republic of)