Supplementary webappendix

Transcription

1 Supplementary webappendix This webappendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. Supplement to: Molyneux E, Nizami SQ, Saha S, et al. 5 versus 10 days of treatment with ceftriaxone for bacterial meningitis in children: a double-blind randomised equivalence study. Lancet 2011; 377:

2 CSF-5 Study Group The Writing Committee of the CSF 5 Study Group: Elizabeth Molyneux, Shaikh Qamaruddin Nizami, Martin Willi Weber and Shamim Ahmad Qazi Contributor ship of CSF-5 Study Group Concept, study design and protocol development (Alphabetical order) Dr. Edwin Asturias Dr. Matloob Azam Dr. Sheila Bird Prof. Neal Halsey Dr. Truong H. Khanh Dr. Laurence Mubaiwa Dr. Shamim Qazi Dr. Martin Weber Dr. Maqsood Yousafzai Institutional Affiliations Johns Hopkins University, USA Pakistan Institute of Medical Sciences, Islamabad, Pakistan MRC Biostatistics Unit, Cambridge, UK Johns Hopkins University, USA Children s Hospital No. 1, Vietnam King Edward VII Hospital, Durban Aga Khan University, Karachi, Pakistan Study implementation and data collection Site (alphabetical order) Principal Investigators Co-investigators Bangladesh Prof. Samir K Saha Prof. Muhammad Hanif Prof. Manzoor Hussain Prof. M Ruhul Amin Prof. M Haider Ali Dr. ASM Nawshad Uddin Ahmed Egypt Prof. Ramadan Gomaa Dr. Hoda Mansour Dr. Yahya Sultan Ahmad Dr. Hassan Abdel Rassoul Malawi Prof. Elizabeth Molyneux Dr. Kondwani Kayira Dr. Kondwani N goma Dr. Kondwani Chiwaya 1

3 Dr. Ajib Phiri Dr. Limangeni Mwankhambo Dr. Hope Forsyth Pakistan, Islamabad and Rawalpindi Prof. Matloob Azam Dr. Rai Asghar Dr. Sajid Farooqi Dr. Masood Ahmad Pakistan, Karachi and Hyderabad Prof. Zulfiqar Ahmad Bhutta Prof. Afroze Ramzan Prof. Hassan Memon Prof. Iqbal Memon Dr. Ghulam Murtaza Dr. A Rehman Siyal Dr. S. M. Mohiuddin Dr.Khalid Mehmood Ahmed Khan Dr.Tufail A.Soomro Viet Nam Dr. Khanh Truong Huu Dr. Tang chi Thuong Dr. Le Phan kim Thoa Dr. Nguyen van Tuan Dr Trinh duy Quang WHO Monitors of the study Dr. Shamim Ahmad Qazi Dr. Martin Willi Weber Institutional Affiliations Data management and Co-ordination and Statistical analysis (alphabetical order) Mr. Noman Afzal Prof. Juanita Hatcher Prof. Qamaruddin Nizami Dr. Shamim Qazi Mr. Shahid Rasool 2

4 Data Safety Monitoring Board (DSMB) Name Prof. Heikki Peltola Prof. Simon Cousens Prof. Urs Schaad Affiliation Helsinki University Children's Hospital, Helsinki, Finland London School of Hygiene and Tropical Medicine Department. of Paediatrics, University of Basel, Switzerland Institutional Affiliations and qualifications (alphabetical order) Dhaka Shishu Hospital, Bangladesh Institute of Child Health, Dhaka Prof. Samir Saha, PhD Prof. Muhammad Hanif, FCPS, FRCP Prof. Manzoor Hussain, FRCP Prof. Muhammad Ruhul Amin FCPS Prof. M Haider Ali, MD Dr. ASM Nawshad Uddin Ahmed, FCPS Abbasia Fever Hospital, Cairo, Egypt Prof. Ramadan Gomaa, MBBCh, MD Dr. Hoda Mansour MBBCh, MSc, MD Microbiology Dr. Yahya Sultan Ahmad, MBBCh, MSc, Dr. Hassan Abdel Rassoul, MBBCh, MSc, University of Malawi Medical School Dept of Pediatrics, Queen Elizabeth Central Hospital, Malawi Prof. Elizabeth Molyneux, FRCPCH Dr. Kondwani Kayira, MBBS Dr. Kondwani N goma, MBBS,MTrop Paeds Dr. Kondwani Chiwaya, MBBS M Trop Paeds Dr. Ajib Phiri, MBBS MMed Paeds (Malawi) Dr. Limangeni Mwankhambo, MBBS MMed Paeds (Malawi) Dr. Hope Forsyth, MRCPCH Royal Liverpool Children s Hospital, United Kingdom Dr. Hope Forsyth, MRCPCH Children s Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan Prof. Matloob Azam, FRCPCH Dr. Masood Ahmad, MBBS, MPH Dr. Sajid Farooqi, MBBS 3

5 Rawalpindi General Hospital, Rawalpindi, Pakistan Aga Khan University, Karachi, Pakistan Dr. Rai Asghar, FCPS Prof. Zulfiqar A Bhutta, FRCPCS Prof. S Q Nizami, FCPS Mr. Noman Afzal BSIT Dr. S M Mohiuddin, MCPS, MRCGP Dr. Juanita Hatcher Liaquat Medical College Hospital, Hyderabad, Pakistan Prof. Hassan Memon, FCPCH Dr. A Rehman Siyal, DCH, MD National Institute of Child Health, Karachi, Pakistan Prof. Afroze Ramzan, FCPS Dr.Khalid Mahmood Ahmed Khan, MCPS,FCPS Dr.Tufail A.Soomro,DCH Civil Hospital, Karachi, Pakistan Prof. Iqbal A Memon, DABP Dr. Ghulam Murtaza, FCPS Viet Nam Dr. Khanh Truong Huu, MD Dr. Tang chi Thuong, MD Dr. Le Phan kim Thoa, MD Dr. Nguyen van Tuan, MD Dr Trinh duy Quang, MD 4

6 WEB Table 1. Deaths in relation to organisms, time of death and HIV status (n= 41) Treatment Group Total 5-day therapy 10-day therapy Organisms H. influenzae b S. pneumoniae N. meningitides None HIV status Negative H. influenzae b S. pneumoniae N. meningitides None Positive H. influenzae b S. pneumoniae N. meningitides None HIV status Not known/not tested H. influenzae b S. pneumoniae N. meningitides None Death after randomization on Day 5

7 Before day Between day 10 to day After day Total