Comparative, Double-blind, Randomized, Prospective, Multicenter Study to Evaluate the Local Tolerability of MK-0826 versus Sodium Ceftriaxone Administered by the Intramuscular Route.
- Conditions
- -J189 Pneumonia, unspecifiedPneumonia, unspecifiedJ189
- Registration Number
- PER-027-00
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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 which is known to be effective against the presumed (s) pathogenic (s) pathogen (s) within a period of 72 days. hours immediately before entering the study. If the patient has received> 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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method