None listed
Conditions
Interventions
Group 1 Type of group
50 mg of tigecycline IV every 12 hours (q 12h)
Group name:Group 2 Type of group
10mg / kg of clindamycin IV (should not exceed 90 (1 mg) every 8 hours (q8h) OR (for subjects who have, in a proven way, a pathogenic microorgmiism resistant to clindamycin) 15 mg / kg of vancomycin IV ( should not exceed 2 g / day and should be adjusted as needed due to renal failure) q8h,
Sponsors
WYETH RESEARCH,
Eligibility
Age
8 Years to 17 Years
Inclusion criteria
Inclusion criteria: • Male or female subjects whose ages range between 8 and 17 years. Children with bone maturation under 8 years of age should enroll with caution due to the possible risk of discoloration of the teeth. • All subjects, both male and female who have a biological ability to conceive, must accept and commit to using a reliable method of contraception throughout the study and during the month following the last dose of the test product. (A subject has a biological ability to conceive even if he uses contraceptives or if his sexual partner is sterile or uses contraceptives). • Presence of a cSSSI that requires hospitalization and administration of IV antibiotic therapy with an expected duration of such therapy greater than or equal to 5 days. • Having a cSSSI that requires significant surgical intervention or that affects deeper soft tissue. • Have at least 3 of the following signs and symptoms: drainage and / or secretion; erythema; swelling and / or induration and / or fluctuation; localized heat; pain and / or tenderness.
Exclusion criteria
Exclusion criteria: • Subjects who suffer, any concomitant disease / pathology or who take any concomitant drug that, at the discretion of the investigator, substantially increases] the risk related to the participation of the subject in the study and / or the end of it, or that may prevent evaluation of the subject´s response (for example, life expectancy <3Ü days). • Be a pregnant or breastfeeding woman. • Have participated in a research study of drugs or devices within 4 weeks prior to the administration of the first dose of the test product. • Contraindication or hypersensitivity to any of the test products that the subject may receive, including tetracycline (for example, anaphylaxis). • Presence of necrotizing fasciitis, gas gangrene, or proven skeletal infection. • Have received potentially effective systemic antibiotics for more than 24 hours before the first dose of the test product to treat the current cSSSI infection, unless the subject has been declared a clinical failure (no clinical improvement was observed after 48 hours of treatment) Or it has been proven that the microorganism is resistant to tigecycline or clindamycin and vancomycin or agents of the same class. • Be suspected of infection or a proven infection caused by a pathogenic microorganism whose resistance to tigecycline or clindamycin and vancomycin is proven (for example, before administration of T.A.). • Subjects receiving immunosuppressive therapy that, at the discretion of the investigator, could reduce the subject´s ability to eradicate the infection, including the use of high doses of corticosteroids. • Hemodialysis, hemofiltration, peritoneal dialysis, or concurrent plasmapheresis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:2 coprimary populations: clinically evaluable population (EC) and population with intent to treat modified clinical (c-mITT). Measure:Respuesta clinica en la visita TOC para 2 poblaciones coprimarias Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The investigator will determine the clinical response in the IV evaluations of LDOT, TOC and FUP. and one of the following results will be assigned; Cure improvement (in LDOT IV only for subjects with changed to oral therapy), failure, or indeterminate. Measure:The clinical response on the last day of IV therapy (LDOT) and visit FUP, Timepoints:During the study ; Outcome name:The investigator will determine the clinical response in the IV evaluations of LDOT, TOC and FUP. and one of the following results will be assigned; Cure improvement (in LDOT IV only for subjects with changed to oral therapy), failure, or indeterminate. Measure:Microbiological responses by subject and by pathogenic microorganism in TOC and FUP visits Timepoints:During the study | — |
Countries
Belgium, Hungaria, Peru, United Kindgdom
Contacts
Public ContactJusto Romulo Padilla
LABORATORIOS WYETH S.A.
Outcome results
None listed