Comparison of the efficacy and possible side effects of high and standard doses of rifampin in the treatment of brucellosis, a randomized clinical trial

Comparison of the efficacy and possible side effects of brucellosis treatment at high doses of rifampin with the usual dose of rifampin

A clinical trial with a control group, with parallel, double-blind, randomized groups on 55 patients, a random number table was used for randomization.

In the first group, he is treated for eight weeks. The second group is given the first four weeks of doxycycline with rifampin in high dose and the next four weeks of doxycycline with the standard dose.

Inclusion criterias are Age less than 14 years؛Innate or acquired immunodeficiency؛Simultaneous infection with advanced or chronic heart, lung, liver and kidney diseases Pregnancy؛Taking oral contraceptives؛Phenytoin use؛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.؛Take antibiotics more than 7 days before the visit؛History of doxycycline or rifampin allergy؛General malaise so that the patient is not able to take the medication orally. Exclusion criteria are All patients with brucellosis, whether hospitalized or referred to a clinic, are included in the plan.

1- Treated with doxycycline 100 mg q 12 h + rifampin 600 mg / day 2- Treated with doxycycline 100 mg q 12h + rifampin 900-1200 mg / day

At the end of the second, fourth, sixth, eighth and three months after the end of treatment, patients should be evaluated for intolerance or drug use, drug side effects, the process of improving clinical symptoms and new symptoms. The persistence of the infection or the failure of treatment will be checked.

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.

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.

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