ID

37970

Beskrivning

Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV-DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form contains information on the microbiology results of the swab samples taken at Visits 1, 4, 5, 6, 7, 8, 9 and 10 (identical for all cohorts).

Nyckelord

Versioner (2)
  1. 2019-08-26 2019-08-26 -
  2. 2019-09-03 2019-09-03 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

3 september 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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10-valent pneumococcal vaccine in HIV-positive, HIV-exposed, and HIV-negative infants - NCT00829010

Engelsk

Swab Microbiology

1 Formulär  
  1. StudyEvent: ODM
    1. Swab Microbiology
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Type
Beskrivning

Fill in this form for all cohorts at all of the visits specified below.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Date of Assessment
Beskrivning

Date of Assessment

Datatyp

date

Alias
UMLS CUI [1]
C2985720
Has a swab sample been collected and received?
Beskrivning

If no, skip the rest of this form except for the signature. If yes, complete the date of sample and following itemgroups.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0563454
UMLS CUI [1,2]
C0884358
UMLS CUI [2,1]
C0183753
UMLS CUI [2,2]
C2585542
Date of sample
Beskrivning

Date of sample

Datatyp

boolean

Alias
UMLS CUI [1]
C1302413
Streptococcus pneumoniae
Beskrivning

Streptococcus pneumoniae

Alias
UMLS CUI-1
C0038410
Microbiological result of Streptococcus pneumoniae
Beskrivning

If positive, answer following questions in this itemgroup.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0025953
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0038410
Please specify serotyping for each Streptococcus pneumoniae culture (Culture 1)
Beskrivning

Please use codes below; specify "other" if applicable

Datatyp

text

Alias
UMLS CUI [1,1]
C0038410
UMLS CUI [1,2]
C0036759
UMLS CUI [1,3]
C0430402
Specify other Streptococcus pneumoniae serotype of culture 1
Beskrivning

if applicable

Datatyp

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0038410
UMLS CUI [1,4]
C0036759
UMLS CUI [1,5]
C0430402
Please specify serotyping for each Streptococcus pneumoniae culture (Culture 2)
Beskrivning

Please use codes below; specify "other" if applicable

Datatyp

text

Alias
UMLS CUI [1,1]
C0038410
UMLS CUI [1,2]
C0036759
UMLS CUI [1,3]
C0430402
Specify other Streptococcus pneumoniae serotype of culture 2
Beskrivning

if applicable

Datatyp

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0038410
UMLS CUI [1,4]
C0036759
UMLS CUI [1,5]
C0430402
Please specify serotyping for each Streptococcus pneumoniae culture (Culture 3)
Beskrivning

Please use codes below; specify "other" if applicable

Datatyp

text

Alias
UMLS CUI [1,1]
C0038410
UMLS CUI [1,2]
C0036759
UMLS CUI [1,3]
C0430402
Specify other Streptococcus pneumoniae serotype of culture 3
Beskrivning

if applicable

Datatyp

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0038410
UMLS CUI [1,4]
C0036759
UMLS CUI [1,5]
C0430402
Has a quantitative count been performed?
Beskrivning

If yes, give result in next item

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0368993
UMLS CUI [1,2]
C0884358
Colony count result
Beskrivning

if applicable

Datatyp

text

Alias
UMLS CUI [1,1]
C0368993
UMLS CUI [1,2]
C0456984
Haemophilus influenzae
Beskrivning

Haemophilus influenzae

Alias
UMLS CUI-1
C0018483
Microbiological result of Haemophilus influenzae
Beskrivning

If positive, answer following questions in this itemgroup.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0025953
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0018483
Please specify serotyping for each Haemophilus influenzae culture (Culture 1)
Beskrivning

Please use codes below

Datatyp

text

Alias
UMLS CUI [1,1]
C0036759
UMLS CUI [1,2]
C0018483
UMLS CUI [1,3]
C0430402
Please specify serotyping for each Haemophilus influenzae culture (Culture 2)
Beskrivning

Please use codes below

Datatyp

text

Alias
UMLS CUI [1,1]
C0036759
UMLS CUI [1,2]
C0018483
UMLS CUI [1,3]
C0430402
Please specify serotyping for each Haemophilus influenzae culture (Culture 3)
Beskrivning

Please use codes below

Datatyp

text

Alias
UMLS CUI [1,1]
C0036759
UMLS CUI [1,2]
C0018483
UMLS CUI [1,3]
C0430402
Has a quantitative count been performed?
Beskrivning

If yes, give result in next item

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0368993
UMLS CUI [1,2]
C0884358
Colony count result
Beskrivning

if applicable

Datatyp

text

Alias
UMLS CUI [1,1]
C0368993
UMLS CUI [1,2]
C0456984
Staphylococcus aureus
Beskrivning

Staphylococcus aureus

Alias
UMLS CUI-1
C0038172
Microbiological result of Staphylococcus aureus
Beskrivning

Microbiological result of Staphylococcus aureus

Datatyp

integer

Alias
UMLS CUI [1,1]
C0025953
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0038172
Other bacteria
Beskrivning

Other bacteria

Alias
UMLS CUI-1
C0205394
UMLS CUI-2
C0004611
Microbiological result of other bacteria
Beskrivning

If positive, answer following questions

Datatyp

integer

Alias
UMLS CUI [1,1]
C0025953
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0004611
Moraxella catarrhalis detected?
Beskrivning

Moraxella catarrhalis detected?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006132
UMLS CUI [1,2]
C0442726
Group A Streptococcus detected?
Beskrivning

Group A Streptococcus detected?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442726
UMLS CUI [1,2]
C1541907
Normal flora detected?
Beskrivning

Normal flora detected?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0314761
UMLS CUI [1,2]
C0442726
Other bacteria detected?
Beskrivning

If yes, specify in next item

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0004611
UMLS CUI [1,3]
C0442726
Specify other detected bacteria
Beskrivning

Specify other detected bacteria

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0442726
UMLS CUI [1,3]
C0004611
UMLS CUI [1,4]
C1521902
Investigator's Signature
Beskrivning

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beskrivning

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Investigator Signature Date
Beskrivning

Investigator Signature Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Printed Investigator's name
Beskrivning

Investigator Name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Tillbaka till toppen

Similar models

Swab Microbiology

1 Formulär
  1. StudyEvent: ODM
    1. Swab Microbiology
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Visit Type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Visit 1 (1)
CL Item
Visit 4 (2)
CL Item
Visit 5 (3)
CL Item
Visit 6 (4)
CL Item
Visit 7 (5)
CL Item
Visit 8 (6)
CL Item
Visit 9 (7)
CL Item
Visit 10 (8)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Swab sample collected and received?
Item
Has a swab sample been collected and received?
boolean
C0563454 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0183753 (UMLS CUI [2,1])
C2585542 (UMLS CUI [2,2])
Date of sample
Item
Date of sample
boolean
C1302413 (UMLS CUI [1])
Item Group
Streptococcus pneumoniae
C0038410 (UMLS CUI-1)
Item
Microbiological result of Streptococcus pneumoniae
integer
C0025953 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0038410 (UMLS CUI [1,3])
Microbiological result of Streptococcus pneumoniae
Code List
Microbiological result of Streptococcus pneumoniae
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not tested (3)
Item
Please specify serotyping for each Streptococcus pneumoniae culture (Culture 1)
text
C0038410 (UMLS CUI [1,1])
C0036759 (UMLS CUI [1,2])
C0430402 (UMLS CUI [1,3])
Serotyping of bacterial culture 1
Code List
Please specify serotyping for each Streptococcus pneumoniae culture (Culture 1)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6A (6A)
CL Item
6B (6B)
CL Item
6C (6C)
CL Item
6D (6D)
CL Item
7A (7A)
CL Item
7B (7B)
CL Item
7C (7C)
CL Item
7F (7F)
CL Item
8 (8)
CL Item
9A (9A)
CL Item
9L (9L)
CL Item
9N (9N)
CL Item
9V (9V)
CL Item
10A (10A)
CL Item
10B (10B)
CL Item
10C (10C)
CL Item
10F (10F)
CL Item
11A (11A)
CL Item
11B (11B)
CL Item
11C (11C)
CL Item
11D (11D)
CL Item
11F (11F)
CL Item
12A (12A)
CL Item
12B (12B)
CL Item
12F (12F)
CL Item
13 (13)
CL Item
14 (14)
CL Item
15A (15A)
CL Item
15B (15B)
CL Item
15C (15C)
CL Item
15F (15F)
CL Item
16A (16A)
CL Item
16F (16F)
CL Item
17A (17A)
CL Item
17F (17F)
CL Item
18A (18A)
CL Item
18B (18B)
CL Item
18C (18C)
CL Item
18F (18F)
CL Item
19A (19A)
CL Item
19B (19B)
CL Item
19C (19C)
CL Item
19F (19F)
CL Item
20 (20)
CL Item
21 (21)
CL Item
22A (22A)
CL Item
22F (22F)
CL Item
23A (23A)
CL Item
23B (23B)
CL Item
23F (23F)
CL Item
24A (24A)
CL Item
24B (24B)
CL Item
24F (24F)
CL Item
25A (25A)
CL Item
25F (25F)
CL Item
27 (27)
CL Item
28A (28A)
CL Item
28F (28F)
CL Item
29 (29)
CL Item
31 (31)
CL Item
32A (32A)
CL Item
32F (32F)
CL Item
33A (33A)
CL Item
33B (33B)
CL Item
33C (33C)
CL Item
33D (33D)
CL Item
33F (33F)
CL Item
34 (34)
CL Item
35A (35A)
CL Item
35B (35B)
CL Item
35C (35C)
CL Item
35F (35F)
CL Item
36 (36)
CL Item
37 (37)
CL Item
38 (38)
CL Item
39 (39)
CL Item
40 (40)
CL Item
41A (41A)
CL Item
41F (41F)
CL Item
42 (42)
CL Item
43 (43)
CL Item
44 (44)
CL Item
45 (45)
CL Item
46 (46)
CL Item
47A (47A)
CL Item
47F (47F)
CL Item
48 (48)
CL Item
unknown (UNK)
CL Item
not applicable (NA)
CL Item
non-encapsulated (NE)
CL Item
other (OTH)
Specify other Streptococcus pneumoniae serotype of culture 1
Item
Specify other Streptococcus pneumoniae serotype of culture 1
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0038410 (UMLS CUI [1,3])
C0036759 (UMLS CUI [1,4])
C0430402 (UMLS CUI [1,5])
Item
Please specify serotyping for each Streptococcus pneumoniae culture (Culture 2)
text
C0038410 (UMLS CUI [1,1])
C0036759 (UMLS CUI [1,2])
C0430402 (UMLS CUI [1,3])
Serotyping of bacterial culture 1
Code List
Please specify serotyping for each Streptococcus pneumoniae culture (Culture 2)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6A (6A)
CL Item
6B (6B)
CL Item
6C (6C)
CL Item
6D (6D)
CL Item
7A (7A)
CL Item
7B (7B)
CL Item
7C (7C)
CL Item
7F (7F)
CL Item
8 (8)
CL Item
9A (9A)
CL Item
9L (9L)
CL Item
9N (9N)
CL Item
9V (9V)
CL Item
10A (10A)
CL Item
10B (10B)
CL Item
10C (10C)
CL Item
10F (10F)
CL Item
11A (11A)
CL Item
11B (11B)
CL Item
11C (11C)
CL Item
11D (11D)
CL Item
11F (11F)
CL Item
12A (12A)
CL Item
12B (12B)
CL Item
12F (12F)
CL Item
13 (13)
CL Item
14 (14)
CL Item
15A (15A)
CL Item
15B (15B)
CL Item
15C (15C)
CL Item
15F (15F)
CL Item
16A (16A)
CL Item
16F (16F)
CL Item
17A (17A)
CL Item
17F (17F)
CL Item
18A (18A)
CL Item
18B (18B)
CL Item
18C (18C)
CL Item
18F (18F)
CL Item
19A (19A)
CL Item
19B (19B)
CL Item
19C (19C)
CL Item
19F (19F)
CL Item
20 (20)
CL Item
21 (21)
CL Item
22A (22A)
CL Item
22F (22F)
CL Item
23A (23A)
CL Item
23B (23B)
CL Item
23F (23F)
CL Item
24A (24A)
CL Item
24B (24B)
CL Item
24F (24F)
CL Item
25A (25A)
CL Item
25F (25F)
CL Item
27 (27)
CL Item
28A (28A)
CL Item
28F (28F)
CL Item
29 (29)
CL Item
31 (31)
CL Item
32A (32A)
CL Item
32F (32F)
CL Item
33A (33A)
CL Item
33B (33B)
CL Item
33C (33C)
CL Item
33D (33D)
CL Item
33F (33F)
CL Item
34 (34)
CL Item
35A (35A)
CL Item
35B (35B)
CL Item
35C (35C)
CL Item
35F (35F)
CL Item
36 (36)
CL Item
37 (37)
CL Item
38 (38)
CL Item
39 (39)
CL Item
40 (40)
CL Item
41A (41A)
CL Item
41F (41F)
CL Item
42 (42)
CL Item
43 (43)
CL Item
44 (44)
CL Item
45 (45)
CL Item
46 (46)
CL Item
47A (47A)
CL Item
47F (47F)
CL Item
48 (48)
CL Item
unknown (UNK)
CL Item
not applicable (NA)
CL Item
non-encapsulated (NE)
CL Item
other (OTH)
Specify other Streptococcus pneumoniae serotype of culture 2
Item
Specify other Streptococcus pneumoniae serotype of culture 2
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0038410 (UMLS CUI [1,3])
C0036759 (UMLS CUI [1,4])
C0430402 (UMLS CUI [1,5])
Item
Please specify serotyping for each Streptococcus pneumoniae culture (Culture 3)
text
C0038410 (UMLS CUI [1,1])
C0036759 (UMLS CUI [1,2])
C0430402 (UMLS CUI [1,3])
Serotyping of bacterial culture 1
Code List
Please specify serotyping for each Streptococcus pneumoniae culture (Culture 3)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6A (6A)
CL Item
6B (6B)
CL Item
6C (6C)
CL Item
6D (6D)
CL Item
7A (7A)
CL Item
7B (7B)
CL Item
7C (7C)
CL Item
7F (7F)
CL Item
8 (8)
CL Item
9A (9A)
CL Item
9L (9L)
CL Item
9N (9N)
CL Item
9V (9V)
CL Item
10A (10A)
CL Item
10B (10B)
CL Item
10C (10C)
CL Item
10F (10F)
CL Item
11A (11A)
CL Item
11B (11B)
CL Item
11C (11C)
CL Item
11D (11D)
CL Item
11F (11F)
CL Item
12A (12A)
CL Item
12B (12B)
CL Item
12F (12F)
CL Item
13 (13)
CL Item
14 (14)
CL Item
15A (15A)
CL Item
15B (15B)
CL Item
15C (15C)
CL Item
15F (15F)
CL Item
16A (16A)
CL Item
16F (16F)
CL Item
17A (17A)
CL Item
17F (17F)
CL Item
18A (18A)
CL Item
18B (18B)
CL Item
18C (18C)
CL Item
18F (18F)
CL Item
19A (19A)
CL Item
19B (19B)
CL Item
19C (19C)
CL Item
19F (19F)
CL Item
20 (20)
CL Item
21 (21)
CL Item
22A (22A)
CL Item
22F (22F)
CL Item
23A (23A)
CL Item
23B (23B)
CL Item
23F (23F)
CL Item
24A (24A)
CL Item
24B (24B)
CL Item
24F (24F)
CL Item
25A (25A)
CL Item
25F (25F)
CL Item
27 (27)
CL Item
28A (28A)
CL Item
28F (28F)
CL Item
29 (29)
CL Item
31 (31)
CL Item
32A (32A)
CL Item
32F (32F)
CL Item
33A (33A)
CL Item
33B (33B)
CL Item
33C (33C)
CL Item
33D (33D)
CL Item
33F (33F)
CL Item
34 (34)
CL Item
35A (35A)
CL Item
35B (35B)
CL Item
35C (35C)
CL Item
35F (35F)
CL Item
36 (36)
CL Item
37 (37)
CL Item
38 (38)
CL Item
39 (39)
CL Item
40 (40)
CL Item
41A (41A)
CL Item
41F (41F)
CL Item
42 (42)
CL Item
43 (43)
CL Item
44 (44)
CL Item
45 (45)
CL Item
46 (46)
CL Item
47A (47A)
CL Item
47F (47F)
CL Item
48 (48)
CL Item
unknown (UNK)
CL Item
not applicable (NA)
CL Item
non-encapsulated (NE)
CL Item
other (OTH)
Specify other Streptococcus pneumoniae serotype of culture 3
Item
Specify other Streptococcus pneumoniae serotype of culture 3
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0038410 (UMLS CUI [1,3])
C0036759 (UMLS CUI [1,4])
C0430402 (UMLS CUI [1,5])
Colony count performed?
Item
Has a quantitative count been performed?
boolean
C0368993 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Item
Colony count result
text
C0368993 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
colony count result
Code List
Colony count result
CL Item
scant (SC)
CL Item
1+ growth (1+)
CL Item
2+ growth (2+)
CL Item
3+ growth (3+)
Item Group
Haemophilus influenzae
C0018483 (UMLS CUI-1)
Item
Microbiological result of Haemophilus influenzae
integer
C0025953 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0018483 (UMLS CUI [1,3])
Microbiological result of Streptococcus pneumoniae
Code List
Microbiological result of Haemophilus influenzae
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not tested (3)
Item
Please specify serotyping for each Haemophilus influenzae culture (Culture 1)
text
C0036759 (UMLS CUI [1,1])
C0018483 (UMLS CUI [1,2])
C0430402 (UMLS CUI [1,3])
Serotyping of bacterial culture 1
Code List
Please specify serotyping for each Haemophilus influenzae culture (Culture 1)
CL Item
unknown (UNK)
CL Item
not applicable (NA)
CL Item
A (A)
CL Item
B (B)
CL Item
C (C)
CL Item
D (D)
CL Item
E (E)
CL Item
F (F)
CL Item
A- (A-)
CL Item
B- (B-)
CL Item
C- (C-)
CL Item
D- (D-)
CL Item
E- (E-)
CL Item
F- (F-)
CL Item
not typeable (NT)
Item
Please specify serotyping for each Haemophilus influenzae culture (Culture 2)
text
C0036759 (UMLS CUI [1,1])
C0018483 (UMLS CUI [1,2])
C0430402 (UMLS CUI [1,3])
Serotyping of bacterial culture 1
Code List
Please specify serotyping for each Haemophilus influenzae culture (Culture 2)
CL Item
unknown (UNK)
CL Item
not applicable (NA)
CL Item
A (A)
CL Item
B (B)
CL Item
C (C)
CL Item
D (D)
CL Item
E (E)
CL Item
F (F)
CL Item
A- (A-)
CL Item
B- (B-)
CL Item
C- (C-)
CL Item
D- (D-)
CL Item
E- (E-)
CL Item
F- (F-)
CL Item
not typeable (NT)
Item
Please specify serotyping for each Haemophilus influenzae culture (Culture 3)
text
C0036759 (UMLS CUI [1,1])
C0018483 (UMLS CUI [1,2])
C0430402 (UMLS CUI [1,3])
Serotyping of bacterial culture 1
Code List
Please specify serotyping for each Haemophilus influenzae culture (Culture 3)
CL Item
unknown (UNK)
CL Item
not applicable (NA)
CL Item
A (A)
CL Item
B (B)
CL Item
C (C)
CL Item
D (D)
CL Item
E (E)
CL Item
F (F)
CL Item
A- (A-)
CL Item
B- (B-)
CL Item
C- (C-)
CL Item
D- (D-)
CL Item
E- (E-)
CL Item
F- (F-)
CL Item
not typeable (NT)
Colony count performed?
Item
Has a quantitative count been performed?
boolean
C0368993 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Item
Colony count result
text
C0368993 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
colony count result
Code List
Colony count result
CL Item
scant (SC)
CL Item
1+ growth (1+)
CL Item
2+ growth (2+)
CL Item
3+ growth (3+)
Item Group
Staphylococcus aureus
C0038172 (UMLS CUI-1)
Item
Microbiological result of Staphylococcus aureus
integer
C0025953 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0038172 (UMLS CUI [1,3])
Microbiological result of Streptococcus pneumoniae
Code List
Microbiological result of Staphylococcus aureus
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not tested (3)
Item Group
Other bacteria
C0205394 (UMLS CUI-1)
C0004611 (UMLS CUI-2)
Item
Microbiological result of other bacteria
integer
C0025953 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0004611 (UMLS CUI [1,4])
Microbiological result of Streptococcus pneumoniae
Code List
Microbiological result of other bacteria
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not tested (3)
Moraxella catarrhalis detected?
Item
Moraxella catarrhalis detected?
boolean
C0006132 (UMLS CUI [1,1])
C0442726 (UMLS CUI [1,2])
Group A Streptococcus detected?
Item
Group A Streptococcus detected?
boolean
C0442726 (UMLS CUI [1,1])
C1541907 (UMLS CUI [1,2])
Normal flora detected?
Item
Normal flora detected?
boolean
C0314761 (UMLS CUI [1,1])
C0442726 (UMLS CUI [1,2])
Other bacteria detected?
Item
Other bacteria detected?
boolean
C0205394 (UMLS CUI [1,1])
C0004611 (UMLS CUI [1,2])
C0442726 (UMLS CUI [1,3])
Specify other detected bacteria
Item
Specify other detected bacteria
text
C0205394 (UMLS CUI [1,1])
C0442726 (UMLS CUI [1,2])
C0004611 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Investigator Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
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