| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS |
| Akutne bakterijske infekcije kože i kožnih struktura.- Croatian |
|
| E.1.1.1 | Medical condition in easily understood language |
| Bacterial infection of the skin. |
| Bakterijske infekcije kože.- Croatian |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
To assess the clinical efficacy of delafloxacin compared with vancomycin
+ aztreonam in patients with ABSSSIs at the Follow-up Visit (Day 14 +/-
1). |
| Procijeniti kliničku učinkovitost delafloksacina u usporedbi s kombinacijom vankomicina i aztreonama u trenutku posjeta za praćenje (14. dan+/-1).- Croatian |
|
| E.2.2 | Secondary objectives of the trial |
•To evaluate the clinical efficacy of delafloxacin compared with
vancomycin + aztreonam by assessing:
-the investigator-assessed response of signs and symptoms of
infection at the Late Follow-up Visit
-the objective clinical response of the reduction of erythema of ≥30%
at 48 to 72 hours
-the investigator assessed response of signs and symptoms of
infection in MRSA patients at the Follow-up Visit
-the reduction in pain at EOT as measured by ePRO
-the microbiological response in MRSA patients
-the microbiological response in all patients
•To evaluate the safety of delafloxacin compared with vancomycin +
aztreonam |
Procijeniti kliničku učinkovitost delafloksacina u usporedbi s kombinacijom vankomicina i aztreonama procjenjujući:
- ispitivačeve procjene odgovora znakova i simptoma infekcije u trenutku kasnog posjeta za praćenje.
- procjenjujući objektivni klinički odgovor smanjenja eritema od ≥ 30 % između 48. i 72. sata.
- prema procjeni ispitivača, procijeniti znakove i simptome infekcije zlatnim stafilokokom otpornim na meticilin u trenutku posjeta za praćenje.
- smanjenje boli na posjeti za kraj liječenja izmjereno ePRO
- mikrobiološki odgovor u ispitanika zaraženih zlatnim stafilokokom otpornim na meticilin
- mikrobiološki odgovor u svih ispitanika
- procijeniti kliničku učinkovitost delafloksacina u usporedbi s kombinacijom vankomicina i aztreonama |
|
| E.2.3 | Trial contains a sub-study | No |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
|
| E.3 | Principal inclusion criteria |
1. Adult (≥18 years of age) men or women.
2. Patients must have a diagnosis of ABSSSI, ie, an infection involving
skin and/or subcutaneous tissues of at least one of the following 4 types
(only the primary infection type will be followed for study purposes):
• Cellulitis/erysipelas: A diffuse skin infection characterized by
spreading areas of redness of a minimum surface area of 75 cm2 as
determined by measurement of the longest head-to-toe length (the
longest dimension of the infection) multiplied
by the longest perpendicular width using a disposable ruler
• Wound infection: An infection characterized by purulent drainagethat is
accompanied by redness of a minimum surface area of 75 cm2 (eg, the
shortest distance of redness extending at least 5 cm from the peripheral
margin of the burn infection) from
a traumatic or surgical wound with surrounding redness of a minimum
surface area of 75 cm2 (eg, the shortest distance of redness extending
at least 5 cm from the peripheral margin of the wound) as determined by
measurement of the longest head-to-toe length (the
longest dimension of the infection) multiplied by the longest
perpendicular width using a disposable ruler
• Major cutaneous abscess: An infection characterized by a collection of
pus within the dermis or deeper that is accompanied by redness of a
minimum surface area of 75 cm2 (eg, the shortest distance of redness
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extending at least 5 cm from the peripheral margin of the abscess) as
determined by measurement of the longest head-to-toe length multiplied
by the longest perpendicular width using a disposable ruler
• Burn infection: An infection characterized by purulent drainage,
redness, edema, and/or induration of a minimum surface area of 75 cm2
(eg, the shortest distance of redness extending at least 5 cm from the
peripheral margin of the burn infection) as determined by measurement
of the longest head-to-toe length multiplied by the longest perpendicular
width using a disposable ruler. Patients with burn infections may only be
enrolled if the area of the burn comprises ≤10% of the patient's body
surface as determined by the investigator
3. Patients must have at least two of the following signs of systemic
infection:
• Lymph node enlargement due to the present infection
• Documented fever ≥38°C/100.4°F taken orally(or the equivalent value for the
temperature recording method used)
• Lymphangitis
• Elevated white blood cells of ≥10,000 cells/μL in the 48 hours prior to
first dose of study drug
• Elevated C reactive protein (>10 × upper limit of normal [ULN]) in the
48 hours prior to first dose of study drug
• Purulent or seropurulent drainage or discharge |
Ispitivanje će uključivati ispitanike (muškarci i žene) u dobi od najmanje 18 godina.
- pacijenti moraju imati dijagnosticiranu bar jednu od sljedeće 4 vrste akutne bakterijske infekcije kože i/ili kožnih struktura (u ispitivačke će se svrhe pratiti samo vrsta primarne infekcije):
- celulitis/erizipel: difuzna infekcija kože karakterizirana rastućim površinama crvenila od najmanje 75 cm2, što se utvrđuje mjerenjem najduže dužine u pravcu glava-pete (najdulja dimenzija infekcije) pomnožene s najdužom poprečnom širinom koristeći ravnalo za jednokratnu uporabu;
- infekcija rane: infekcija karakterizirana gnojnim iscjetkom iz traumatske ili kirurške rane s okolnim crvenilom najmanje površine od 75 cm2 (na primjer, najkraća dužina crvenila koje se proteže najmanje 5 cm od ruba rane), što se utvrđuje mjerenjem najduže dužine u pravcu glava-pete (najdulja dimenzija infekcije) pomnožene s najdužom poprečnom širinom koristeći ravnalo za jednokratnu uporabu;
- veliki kožni apsces: infekcija karakterizirana skupljanjem gnoja u dermisu ili dublje uz pridruženo crvenilo najmanje površine od 75 cm2 (na primjer, najkraća dužina crvenila koje se proteže najmanje 5 cm od ruba apscesa), što se utvrđuje mjerenjem najduže dužine u pravcu glava-pete (najdulja dimenzija infekcije) pomnožene s najdužom poprečnom širinom koristeći ravnalo za jednokratnu uporabu;
- infekcija opekline: infekcija karakterizirana gnojnim iscjetkom, crvenilom, edemom i/ili induracijom najmanje površine od 75 cm2 (na primjer, najkraća dužina crvenila koje se proteže najmanje 5 cm od ruba infekcije opekline), što se utvrđuje mjerenjem najduže dužine u pravcu glava-pete (najdulja dimenzija infekcije) pomnožene s najdužom poprečnom širinom koristeći ravnalo za jednokratnu uporabu. Pacijenti s infekcijom opekline mogu se uključiti samo ako površina opekline čini ≤ 10 % površine tijela prema procjeni ispitivača.
- pacijenti moraju imati bar dva od sljedećih znakova sistemske infekcije:
- povećanje limfnih čvorova zbog postojeće infekcije;
- dokumentirana vrućica ≥ 38 C/100,4 F oralno izmjerena (ili jednaka vrijednost za korištenu metodu mjerenja temperature);
- limfangitis;
- povećan broj bijelih krvnih zrnaca od ≥ 10.000 zrnaca/μl 48 sati prije primanja prve doze ispitivanog lijeka;
- gnojni iscjedak ili iscjedak mješavine gnoja i seruma; (Croatian) |
|
| E.4 | Principal exclusion criteria |
1. Medical history of significant hypersensitivity or allergic reaction to
quinolones, beta-lactams, vancomycin, or vancomycin derivatives
according to the judgment of the investigator.
2. Women who are pregnant or lactating.
3. Any chronic or underlying skin condition at the site of infection that
may complicate the assessment of response (eg, atopic dermatitis or
eczema). Any other skin condition that, in the opinion of the
investigator, would interfere with objective measurement of the ABSSSI
under treatment.
4. Infection associated with a prosthetic joint or the removal of a
prosthetic joint, or infection involving other prosthetic materials or
foreign bodies (eg, catheter tunnels) unless that other prosthetic
material will be removed within 24 hours after starting study drug. |
1. Povijest znatne preosjetljivosti ili alergijske reakcije na kinolone, beta-laktame, vankomicin ili derivate vankomicina prema prosudbi ispitivača.
2. Trudnice i dojilje.
3. Bilo koje stanje kože na mjestu infekcije koje bi moglo zakomplicirati procjenu odgovora (na primjer, atopični dermatitis ili ekcem). Bilo koje drugo stanje kože koje bi prema mišljenju ispitivača ometalo objektivno mjerenje akutne bakterijske infekcije kože i kožnih struktura koja se liječi.
4. Infekcija povezana s prostetičkim zglobom ili uklanjanjem prostetičkog zgloba ili infekcija koja uključuje druge prostetičke materijale ili strana tijela (na primjer, kateteri) osim ako će drugi prostetički materijal biti uklonjen u roku od 24 sata nakon početka primanja ispitivanog lijeka.
(Croatia) |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Investigator-assessed response of signs and symptoms of infection at
the Follow-up Visit. |
| Po procjeni ispitivača odgovor na znakove i simptome infekcije na posjetu za praćenje. (Croatia) |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Day 14 +/- 1 after initiation of treatment. |
| Dan 14+/-1 nakon početka liječenja.(Croatia) |
|
| E.5.2 | Secondary end point(s) |
Objective measures of clinical efficacy as detailed in the
protocol will be assessed at baseline and at multiple time points
during the study. Infection area measurements will be obtained
using several methodologies at Screening, Day 1, Day 2, twice
on Day 3 (12 hours apart), Day 4, End of Treatment, Follow-up,
and Late Follow-up |
| Objektivne mjere kliničke učinkovitosti navedene u planu ispitivanja procjenjivat će se u trenutku utvrđivanja početnih vrijednosti i još nekoliko puta tijekom ispitivanja. Površina infekcije mjerit će se korištenjem nekoliko metodologija na probiru te 1. dan, 2. dan, dva puta 3. dan (u razmaku od 12 sati), 4. dan te na posjetu za kraj liječenja, posjetu za praćenje i posjetu za kasno praćenje.(Croatia) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| 48 to 72 hours after initiation of treatment |
| 48 do 72 sata nakon početka liječenja.-Croatian |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Yes |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | Yes |
| E.6.8 | Bioequivalence | Yes |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | Yes |
| E.6.11 | Pharmacogenomic | Yes |
| E.6.12 | Pharmacoeconomic | Yes |
| E.6.13 | Others | No |
| E.6.13.1 | Other scope of the trial description |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 41 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Bulgaria |
| Croatia |
| Hungary |
| Israel |
| Korea, Republic of |
| Latvia |
| Lithuania |
| Romania |
| Russian Federation |
| Ukraine |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Patients will receive a follow up telephone call 30 days after their last
dose of study drug to assess patient status and to check for AEs and
posttreatment medications. |
| Ispitanike će se nazvati telefonom 30 dana nakon njihove zadnje doze ispitivanog lijeka kako bi se procijenio status ispitanika i kako bi se provjerilo da li ima neželjenih događaja te koji lijekovi se uzimaju nakon ispitivanja.(Croatian) |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 15 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 15 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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