INFORMATION AND CONSENT FORM
ID #________________
Date____/_____/_____
Dear ____________________________
My name is Dr Agantem Ekuma of the Department of Medical Microbiology and Parasitology, Lagos University Teaching Hospital, Idi-Araba. I am carrying out a study to check for the presence of germs called Enterococcus which are resistant to the antibiotic vancomycin. These germs can easily be transferred among patients who are on admission for a long time and can cause infections that are difficult to treat in patients who are seriously ill.
What do I have to do?
I will ask you questions about you, your illness and the drugs you are taking. I will also require a stool sample from you.
Discomfort and Risks
Taking a swab may cause mild discomfort but will not cause you any pain or injury. It will not in any way affect you.
Benefits
This study will enable us know more about this bacteria so we can prevent its spread within this hospital.
Confidentiality statement
The information you give shall be kept very confidential, your name will not be on the questionnaire and codes will be given to you. The register that link to you to the questionnaire will be locked in a secure cabinet. The records concerning your participation are to be used only for the purpose of this research.
55 Your contribution
If you participate in this study you will be contributing to increasing our knowledge about this bacteria and helping us to prevent its spread among patients in this hospital.
Freedom to withdraw
You are free to refuse to take part in this study, and the quality of care you are receiving will not be compromised in any way.
Questions
If you have any questions concerning this research study, you may ask now or any time during the study. You may contact any of the following:
1. The Chairman of the ethical committee, Dr Njideka U. Okubadejo, MBCHB, FMCP Associate Professor & Consultant Neurologist, Lagos University Teaching Hospital
PMB 12003, Lagos State, Nigeria
Tel: +2348023130243. Email : [email protected] 2. Dr Agantem Ekuma
Dept of Medical Microbiology Lagos University Teaching Hospital
Tel: 08023075572. Email:[email protected]
Sincerely,
Dr Agantem Ekuma
56 Participant statement
I have been informed verbally and in writing about this study and understand what is involved. I know that I do not have to take part in this study but I chose to do so. I also understand that I can withdraw at any time without any loss in my privilege as a patient.
Name of patient _____________________________________________________________
Thumbprint or Signature of Patient ______________________ Date______________
______________________________ ______________________________
Witness Date
Investigators statement
I, the undersigned, have described and explained the procedures of this study, its aims and the risks and benefits and benefits associated with participation and he/she understands, I have informed him/her that confidentiality will be preserved, that he/she is free to withdraw from the study any time without any loss in the quality of care. Following these, the volunteer agreed to participate in this study.
Name of investigator __________________________________________
Sign ______________________________ Date __________________________________
57 VANCOMYCIN RESISTANT ENTEROCOCCI IN PATIENTS ON
PROLONGED HOSPITALIZATION IN LUTH
QUESTIONNAIRE/PROFORMA
PATIENT’S DETAILS
Study no______________________ Hospital no ____________________ Ward____________
Date of birth/Age _________________________ Gender: Male Female CLINICAL DETAILS
Indication (diagnosis) for admission ____________________________________________________
Date of admission ____________________ Date of specimen collection ___________________
ANTIMICROBIAL HISTORY
Antibiotic used in the last three months: Yes ( ) No ( ) If yes, which
Vancomycin Cefotaxim Ceftriaxone Ceftazidime
Cefuroxime Levofloxacin Ciprofloxacin Co-amoxiclav Cotrimoxazole Amikacin Metronidazole
Any other (specify) _________________________________________________________________
__________________________________________________________________________________
Antibiotic administered during present admission: Yes ( ) No ( ) If yes, which
Vancomycin Cefotaxim Ceftriaxone Ceftazidime
Cefuroxime Levofloxacin Ciprofloxacin Co-amoxiclav Cotrimoxazole Amikacin Metronidazole
Any other (specify) _________________________________________________________________
__________________________________________________________________________________
Route of administration: oral parenteral
No of admissions in the past year ______________________________________________________
Use of invasive device: Yes/No CV line Foley catheter Mech. ventilation Others (specify) ______________________________________________________________
Antineoplastic chemotherapy _________________________________________________________
__________________________________________________________________________________
Operative status ____________________________________________________________________
Total WBC count (latest) ______________________________________________________
APACHE II score: ___________________________________________________________
Renal insufficiency Any co-morbidity ____________________________________
Cefepime Meropenem Cefepime Meropenem
58 Table 6.1: Characteristics and antimicrobial susceptibility* profile of VRE isolates
ID Specie Van
Genotype
MIC (mg/liter)
Va Te Am Ci Li Ge
A E. faecium vanA >256 (R) 48 (R) >256 (R) >32 (R) 1.5 (S) 12
B E. faecium vanB 8 (I) 1 (S) >256 (R) >32 (R) 0.5 (S) >512 (HLR)
C E. faecium vanB 8 (I) 0.38 (S) >256 (R) >32 (R) 1.5 (S) >512 (HLR)
D E. gallinarum vanC1 1 (S) 0.5 (S) 1 (S) 4 (R) 2 (S) 8
E E. gallinarum vanC1 8 (I) 1.5 (S) 0.75 (S) >32 (R) 0.75 (S) >512 (HLR)
F E. gallinarum vanC1 8 (I) 0.75 (S) 1.5 (S) 0.75 (S) 1 (S) 4
G E. gallinarum vanC1 8 (I) 1 (S) 0.5 (S) 1 (S) 1 (S) 2
H E. gallinarum vanC1 4 (S) 1 (S) 0.75 (S) >32 (R) 0.5 (S) >512 (HLR)
I E. gallinarum vanC1 1 (S) 0.5 (S) 2 (S) 2 (I) 1.5 (S) 4
J E. gallinarum vanC1 8 (I) 0.75 (S) 2 (S) 3 (R) 2 (S) 4
K E. gallinarum vanC1 4 (S) 0.75 (S) 0.75 (S) >32 (R) 0.75 (S) 2
L E. gallinarum vanC1 4 (S) 1 (S) 0.5 (S) 0.75 (S) 0.75 (S) 2
M E. gallinarum vanC1 4 (S) 0.75 (S) 0.75 (S) 1.5 (I) 1 (S) 2
N E. casseliflavus vanC2 8 (I) 0.75 (S) 0.125 (S) 16 (R) 0.75 (S) 2
MIC – Minimum inhibitory concentration; Va – Vancomycin; Te – Teicoplanin; Am – Ampicillin; Ci – Ciprofloxacin; Li – Linezolid; Ge – Gentamicin
* Using CLSI breakpoints
59 Fig 5. Bile Esculin broth with vancomycin used for enrichment
Fig 6. Bile Esculin Agar used for detection of enterococci
Fig 7. VITEK MS MALDI-TOF used for identification of
enterococcal species