None listed
Conditions
Interventions
Group 1 Type of group
MK-0826 at a single daily dose of 1 gr IM for 7 days
Group name:Group 2 Type of group
Ceftriaxone in a single dose of 1 gr IM for 7 days
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients> 18 years of age with lower respiratory tract infection (ITRI), skin or soft tissue infection or urinary tract infection (UTI), as defined below, are suitable for inclusion. Both men and women are eligible. • Women of childbearing age whose urine pregnancy test is negative are eligible to enter the study; however, they must have a negative blood pregnancy confirmatory test (B-HCG). The use of appropriate measures for birth control should be discussed with the investigator. Hormonal contraceptives should not be used as the sole method of birth control because the effect of MK-0826 on the effectiveness of hormonal contraceptives has not yet been established. Breastfeeding women can participate if they agree to suspend breastfeeding for up to 5 days after the completion of therapy in order to allow the elimination of the drug from breast milk. • The patient´s infection should be severe enough to require I.M. therapy. and patients are expected to require a minimum of 2 doses (ie, 2 days) but no more than 7 doses of I.M. therapy. • At the investigator´s discretion, the patient´s infection is caused by microorganisms susceptible to the study antibiotics administered via I.M. See also the Criteria for Patients with ITRI (Infection of the Lower Respiratory Tract) which are found below for the case of subjects with possible atypical respiratory pathogens. • The patient´s infection has been treated using systemic antibiotic therapy for 24 hours of systemic antimicrobial therapy, there must be clear evidence that the patient did not respond to this regimen. Such evidence would include continued fever and persistence or worsening of symptoms related to the initial infection and / or laboratory changes or persistent radiographic or positive cultures. • Meets criteria for lower respiratory tract infection (community acquired pneumonia and acute exacerbation of chronic bronchitis) and skin infections.
Exclusion criteria
Exclusion criteria: 1) Does not meet all the inclusion criteria. 2) History of coagulation problems or the patient is on anticoagulatory therapy. 3) Patients who have received some intragluteal IM therapy in the previous 48 hours. 4) Patients with some local pathology (for example: cellulitis, abscesses, ulcer) in the gluteal region. 5) Infections known at the time of admission that are caused by pathogens resistant to any of the study drugs. This includes those patients who are at risk for anaerobic infections. Note: A macrolide can be added in case of suspicion of the existence of atypical respiratory pathogens. 6) History of serious allergy, hypersensitivity (for example: anaphylaxis) or any adverse reaction to antibiotics of the family carbapenem (such as imipenem), ceftriaxone sodium or any cephalosporin or penicillin. Patients with a history of mild rash (not urticaria) to penicillins or other beta-lactams can be enrolled. 7) History of severe allergy, hypersensitivity, intolerance or any other adverse reaction to lidocaine or other similar local anesthetic agents. Also, patients with severe shock or heart block. 8) Pregnant women, women who breastfeed or women of childbearing age who do not practice adequate methods of contraception; women who plan to get pregnant within the period of a month of the study. Those women who choose to stop breastfeeding for up to 5 days after the last dose of the study drug with the aim of allowing the elimination of the drug from breast milk will be eligible. 9) Rapidly progressive or terminal disease, patients in whom a response to the antibiotic regimens described in this study or patients whose chances of surviving the study period are unlikely is considered unlikely. 10) Patients who are hemodynamically unstable defined as: Limbs with poor perfusion, Pulse at rest> 100 bpm and systolic pressure <90 mm, Hg with the need for pressure or volume repletion, 11) Signs of meningitis, such as stiff neck, papilledema or other findings of meningitis. The penetration of cerebrospinal fluid by MK-0826 has not yet been determined. 12) Patients who have received adequate antimicrobial therapy for 24 hours or more in the 72 hours prior to enrollment, unless there is a clear indication that the patient did not respond to this regimen as specified in the inclusion criteria. 13) The need for concomitant systemic antimicrobials in addition to the study antibiotics, with the exception of macrolide therapy for possible atypical respiratory pathogens (for example: mycoplasma, chlamydia). 14) Concurrent infection or other disease that, in the opinion of the investigator, interferes with the evaluation of the response to the study antibiotic or represents an additional risk in the administration of the study drug to the patient. 15) Patients with a history or clinical signs suggestive of active tuberculosis or who are currently on therapy for tuberculosis. 16) Chronic immunosuppressive therapy, which includes the use of high doses of corticosteroids (greater than or equal to 40 mg of prednisone daily or its equivalent), diagnosis of AIDS by current CDC criteria or patients with organ transplantation. 17) Hematocrit <25% or hemoglobin <8 g / dL. 18) Neutropenia with absolute neutrophil count (ANC) <1000 / mm ^. 19) Platelet count <100. 000 / mm3. 20) Clotting tests (prothrombin time [PT] and partial thromboplastin time [PTT]) outside the range of normal value
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:• Healing: Complete or considerable solution of the signs and symptoms of active infection (without the worsening thereof, without requiring any additional therapy with antibiotics and without a previous evaluation of failure). • Improvement: This evaluation can only be done during the I.M. therapy discontinuation visit: improvement in most of the signs and symptoms of the index infection. The patient can be switched to oral study therapy. • Failure: death caused by any cause, persistence, partial solution or worsening of signs and symptoms of admission and / or appearance of new signs or symptoms of index infection and / or need for additional antimicrobial therapy, which does not belong to the study, • Undetermined: Information about the study is not available for evaluation of efficacy due to some reason, including: circumstances that exclude classification as a cure or failure, for some reason, the patient was withdrawn before sufficient clinical information could be obtained. Measure:Efficacy Timepoints:At the post-therapy follow-up visit 7 to 14 days after and at the time of the discontinuation of the study antibiotic administered intramuscularly. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Record of adverse experiences in the Reports of Cases of Adverse Experiences of the work booklet. Measure:Safety Timepoints:Duration of the study | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed