Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA

PHASE3CompletedINTERVENTIONAL
Enrollment

199

Participants

Timeline

Start Date

March 30, 2017

Primary Completion Date

January 1, 2024

Study Completion Date

January 1, 2024

Conditions
Methicillin-Resistant Staphylococcus AureusBacterial InfectionsStaphylococcal Skin Infections
Interventions
DRUG

Dalbavancin

Dalbavancin was administered intravenously over 30 (± 5) minutes.

DRUG

Vancomycin

Vancomycin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.

DRUG

Oxacillin

Oxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.

DRUG

Flucloxacillin

Flucloxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.

DRUG

Cefadroxil

Cefadroxil was administered orally every 12 hours.

DRUG

Clindamycin

Clindamycin was administered orally every 8 hours.

Trial Locations (84)

159

LEPL Tbilisi State Medical University Givi Zhvania Academic Clinic of Pediatry /ID# 235645, Tbilisi

LTD M. Iashvili Children's Central Hospital /ID# 235639, Tbilisi

LTD Unimedi Kakheti Children New Hospital /ID# 235634, Tbilisi

1004

Hospital Valle del Sol /ID# 235569, Guatemala City

1011

Hospital Roosevelt /ID# 235520, Guatemala City

1016

Hospital del Centro Medico Infectology Department /ID# 235522, Guatemala City

1055

Mzansi Ethical Research Center /ID# 236480, Middelburg

1606

MHATEM N.I.Pirogov Septic Surgery Clinic /ID# 235541, Sofia

1619

Peermed Clinical Trial Centre /ID# 235514, Kempton Park

1756

SHAT Hematologic Diseases /ID# 237915, Sofia

3000

Hospital de Ninos Dr. Orlando Alassia /ID# 235562, Santa Fe

3320

MHAT (Multiprofile Hospital for Active Treatment) /ID# 235539, Kozloduy

4000

Multiprofile Hospital for Active Treatment ( UMHAT) Sveti Georgi EAD Plovdiv /ID# 235487, Plovdiv

4002

UMHAT Sveti Georgi /ID# 237026, Plovdiv

5400

Medical center 1 Sevlievo /ID# 237470, Sevlievo

5800

UMHAT Dr Georgi Stranski EAD /ID# 237829, Pleven

UMHAT Dr Georgi Stranski EAD /ID# 237830, Pleven

6000

University Multiprofile Hospital for Active Treatment Prof. Dr. Stoyan Kirkovich /ID# 235543, Stara Zagora

6010

LTD Unimedi Kakheti Batumi Maternal and Child Healthcare Center /ID# 235643, Batumi

7002

UMHAT Kanev /ID# 237809, Rousse

8000

University Multiprofile Hospital for Active Treatment Deva Maria EOOD Burgas /ID# 235965, Bulgas

10016

NYU School of Medicine /ID# 236783, New York

12462

University General Hospital Attikon /ID# 237398, Athens

13210

SUNY Upstate Medical University /ID# 236831, Syracuse

15076

Complejo Hospitalario Universitario de Santiago /ID# 235512, Santiago de Compostela

15236

Childrens Hospital of Penteli /ID# 235667, Athens

20014

Hospital Donostia /ID# 237773, Donostia / San Sebastian

25006

PE PMC Acinus, Medical and Diagnostic Center /ID# 237514, Kropyvnytskyi

25175

Unidad De Investigacion Clinica Universidad De La Sabana /ID# 235566, Chía

28007

Hospital General Universitario Gregorio Maranon /ID# 236955, Madrid

28046

Hospital Universitario La Paz /ID# 237775, Madrid

32405

Global Research Holdings LLC /ID# 235747, Panama City

33606

Tampa General Hospital /ID# 237061, Tampa

36004

Ukrainian Medical Stomatological Academy - Children's City Clinical Hospital /ID# 234886, Poltava

44195

Cleveland Clinic Main Campus /ID# 237564, Cleveland

46026

Hospital Universitario y Politecnico La Fe /ID# 237086, Valencia

49100

Dnipropetrovsk Regional children's Clinical Hospital /ID# 235558, Dnipro

50010

Hospital Universitario San Vic /ID# 238117, Medellín

50161

Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 236947, Kaunas

54642

General Hospital of Thessaloniki Hippokrateio /ID# 237186, Thessaloniki

55536

Papageorgiou General Hospital Thessaloniki /ID# 237505, Stavroupoli (Thessalonikis)

64108

Duplicate_Children's Mercy Hospital and Clinics /ID# 237800, Kansas City

64460

Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 237597, Monterrey

76006

Ivano-Frankivsk Pediatric Regional Clinical Hospital /ID# 235556, Ivano-Frankivsk

79010

Lviv Regional Clinical Hospital /ID# 236921, Lviv

80045

Duplicate_Children's Hospital Colorado /ID# 237622, Aurora

88000

"Communal Nonprofit Enterprise Central City Clinical Hospital of Uzhhorod City /ID# 238058", Uzhhorod

90095

University of California, Los Angeles /ID# 237533, Los Angeles

90623

Southbay Pharma Research /ID# 235700, La Palma

97000

Hospital General Dr. Agustin O'Horan /ID# 235510, Mérida

111156

Fundacion Cardioinfantil /Id# 238041, Bogota

160022

Regional Childrens Hospital /ID# 235560, Vologda

210015

Vitebsk Regional Clinical Center for Children /ID# 235659, Vitebsk

212026

Mogilev Regional Children's Hospital /ID# 235657, Mogilev

214019

Smolensk State Medical University /ID# 236996, Smolensk

230030

Grodno Regional Infectious Disease Hospital /ID# 235661, Grodno

355017

Stavropol State Medical University /ID# 236239, Stavropol

500063

Spitalul Clinic de Urgenta pentru Copii ?Louis Turcanu? /ID# 235608, Timișoara

540142

Spitalul Clinic Judeatean Mures /ID# 234728, Târgu Mureş

8320000

Hospital El Carmen de Maipú /ID# 235570, Santiago

8380418

Hospital de Ninos Dr. Roberto del Rio /ID# 235568, Independencia

36604-3302

University of South Alabama /ID# 237446, Mobile

85008-4973

Valleywise Health Medical Center /ID# 234343, Phoenix

30342-1605

Children's Healthcare of Atlanta - Ferry Rd /ID# 237003, Atlanta

21201-1544

University of Maryland Medical Center /ID# 234353, Baltimore

08901

Robert Wood Johnson Univ Hosp /ID# 237862, New Brunswick

27705-4410

Duke University Medical Center /ID# 234315, Durham

80250-060

Duplicate_Hospital Pequeno Princípe /ID# 235629, Curitiba

90035-074

Duplicate_Irmandade Santa Casa de Misericórdia de Porto Alegre /ID# 235627, Porto Alegre

LV-5401

Daugavpils Regional Hospital /ID# 237022, Daugavpils

LV-3414

Liepaja Regional Hospital /ID# 235650, Liepāja

LV-1004

University Childrens Hospital /ID# 235648, Riga

LT- 92144

Klaipeda Children's Hospital /ID# 235652, Klaipėda

LT-08661

Duplicate_Children's Hospital Affiliate - Vilnius University Hospital Santariski /ID# 235654, Vilnius

04530

Instituto Nacional de Pediatria /ID# 235506, Coyoacán

06720

Hospital Infantil de Mexico Federico Gomez /ID# 235508, Mexico City

Unknown

Hospital Materno Infantil José Domingo de Obaldía /ID# 235625, Chiriquí

0816-00383

Hospital Del Niño Dr. José Renán Esquivel /ID# 235572, Panama City

85-030

Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 236920, Bydgoszcz

02-507

Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 237112, Warsaw

60-734

Specjalistyczny ZOZ nad Matka i Dzieckiem w Poznaniu Oddzial Obserwacyjno /ID# 235518, Poznan

021105

Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 235606, Sector 2

030303

Spitalul Clinic de Boli infectioase si Tropicale Dr. Victor Babes /ID# 235610, Bucharest

08950

Hospital Sant Joan de Deu /ID# 236797, Esplugues de Llobregat

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