NCT02424734 - Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 4, 2015

Primary Completion Date

December 26, 2017

Study Completion Date

December 26, 2017

Conditions

Late-onset Sepsis

Interventions

DRUG

Ceftaroline Fosamil

Ceftaroline fosamil will be given at a dose of 6 mg/kg IV over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour).

DRUG

Ampicillin

Ampicillin IV is required for the first 48 hours if the presence of an organism that requires treatment with ampicillin cannot be excluded. Will be given as per local standard of care.

DRUG

Aminoglycoside

Optional, will be given as per local standard of care.

Trial Locations (4)

1097

Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet, Gyermekinfektologiai Osztaly, Budapest

1125

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak, Gyermek-, Koraszulott es Csecsemoosztaly, Budapest

4400

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Gyermekosztaly, Nyíregyháza

92123

Rady Children's Hospital San Diego, San Diego