Information:
Fel:
ID
30486
Beskrivning
https://clinicaltrials.gov/ct2/show/NCT00344006 Study ID : CDA 714703/005 Clinical Study ID :714703/005 Study Title :A multi-centre, randomised, double-blind, double dummy study comparing the efficacy and safety of chlorproguanil-dapsone-artesunate versus artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in children and adolescents in Africa. Patient Level Data : Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier : NCT00344006 Sponsor : GlaxoSmithKline Collaborators : N/A Phase phase :3 Study Recruitment Status : Completed Generic Name : artesunate/chlorproguanil/dapsone Trade Name : LAPDAP + ARTESUNATE Study Indication : Malaria, Falciparum
Länk
https://clinicaltrials.gov/ct2/show/NCT00344006
Nyckelord
Versioner (1)
- 2018-06-08 2018-06-08 - Halim Ugurlu
Rättsinnehavare
GlaxoSmithKline (GSK)
Uppladdad den
8 juni 2018
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
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NCT00344006-Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria
Case Report From, Module Number 1.1 (Visits included in this module: Screening, Pre-Dose)
Similar models
Case Report From, Module Number 1.1 (Visits included in this module: Screening, Pre-Dose)
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic Ancestry
integer
C3841890 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
C0034510 (UMLS CUI [1,2])
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Item
Temperature Location
integer
C2826699 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,2])
CL Item
Axilla (3)
CL Item
Tympanic (4)
Item Group
Urine Sample for Chloroquine
C0200354 (UMLS CUI-1)
C0008269 (UMLS CUI-2)
C0008269 (UMLS CUI-2)
Item
Was Chloroquine detected in the urine sample?
integer
C0200354 (UMLS CUI [1,1])
C0008269 (UMLS CUI [1,2])
C0008269 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
Not Done (4)
Item Group
Urine Sample for Sulphonamide
C0200354 (UMLS CUI-1)
C0038760 (UMLS CUI-2)
C0038760 (UMLS CUI-2)
Item
Was Sulphonamide detected in the urine sample?
integer
C0200354 (UMLS CUI [1,1])
C0038760 (UMLS CUI [1,2])
C0038760 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
Not Done (4)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (not of childbearing potential or male) (3)
Item Group
MALARIA PARASITOLOGY - SINGLE ASSESSMENT
C3661511 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI-2)
Sample Time
Item
Sample Time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
Item Group
MALARIA PARASITOLOGY - SINGLE ASSESSMENT
C3661511 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI-2)
CL Item
P. falciparum (1)
CL Item
P. vivax (2)
CL Item
P. ovale (3)
CL Item
P. malariae (4)
CL Item
Unknown (5)
CL Item
Positive (POS)
CL Item
Negative (NEG)
Count
Item
Count /UL
text
C0750480 (UMLS CUI [1])
Item Group
GAMETOCYTE - SINGLE ASSESSMENT
C0686869 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI-2)
CL Item
P. falciparum (1)
CL Item
P. vivax (2)
CL Item
P. ovale (3)
CL Item
P. malariae (4)
CL Item
Unknown (5)
CL Item
Positive (POS)
CL Item
Negative (NEG)
Count
Item
Count /UL
text
C0750480 (UMLS CUI [1])
Medical Conditions
Item
Does the subject have any past or current medical conditions?
boolean
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Current/Past
text
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0521116 (UMLS CUI [2])
C1444637 (UMLS CUI [1,2])
C0521116 (UMLS CUI [2])
CL Item
Current (1)
CL Item
Past (2)
Item Group
History of malaria
C2239174 (UMLS CUI-1)
C0024530 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0024530 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
Item
Has the subject had a malarial episode in the past?
integer
C2239174 (UMLS CUI [1,1])
C0024530 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0024530 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
number of confirmed episodes
Item
If Yes, provide number of confirmed episodes of malaria in the past 12 months:
integer
C4086638 (UMLS CUI [1,1])
C0024530 (UMLS CUI [1,2])
C0024530 (UMLS CUI [1,2])
Item Group
LABORATORY RESULT DATA (HAEMATOLOGY)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
Laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Address
Item
Address
text
C3262820 (UMLS CUI [1])
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
WBC Result
Item
WBC Result
text
C0023508 (UMLS CUI [1])
RBC Result
Item
RBC Result
text
C1287262 (UMLS CUI [1])
Haemoglobin Result
Item
Haemoglobin Result
text
C0518015 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
Haematocrit Result
Item
Haematocrit Result
text
C0018935 (UMLS CUI [1])
Absolute Reticulocytes
Item
Absolute Reticulocytes
text
C0206161 (UMLS CUI [1])
Reticulocytes (Percentage)
Item
Reticulocytes (Percentage)
text
C1167975 (UMLS CUI [1])
Platelets
Item
Platelets
text
C0005821 (UMLS CUI [1])
Methaemoglobin Result
Item
Methaemoglobin Result
text
C1274040 (UMLS CUI [1,1])
C0025635 (UMLS CUI [1,2])
C0025635 (UMLS CUI [1,2])
ELIGIBILITY QUESTION
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Acute, uncomplicated P. falciparum malaria
Item
Acute, uncomplicated P. falciparum malaria, microscopically confirmed infection of 2,000 - 200,000 parasites/ uL.
boolean
C0032150 (UMLS CUI [1,1])
C2930826 (UMLS CUI [1,2])
C2930826 (UMLS CUI [1,2])
High tympanic temperature or confirmed history of fever
Item
Tympanic temperature at screening of >=37.5 degrees C or confirmed history of fever within the previous 24 hours.
boolean
C0041445 (UMLS CUI [1,1])
C0005903 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])
C0005903 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])
Male or female child.
Item
Male or female child.
boolean
C0870221 (UMLS CUI [1,1])
C0870604 (UMLS CUI [1,2])
C0870604 (UMLS CUI [1,2])
Age
Item
Aged >= 12 months, up to and including 14 years old.
boolean
C0001779 (UMLS CUI [1])
Weight
Item
Weight >=7.5kg.
boolean
C0005910 (UMLS CUI [1])
haemoglobin and haematocrit values
Item
Screening haemoglobin of >= 7g/dl, or haematocrit of >=25% (if Hb not available at screening)
boolean
C0518015 (UMLS CUI [1,1])
C0018935 (UMLS CUI [1,2])
C0018935 (UMLS CUI [1,2])
Willingness to comply with the study
Item
Willingness to comply with the study visits and procedures, as outlined in the informed consent form.
boolean
C0600109 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1321605 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
consent
Item
Written or oral witnessed consent has been obtained from parent or guardian.
boolean
C0021430 (UMLS CUI [1])
Assent is given
Item
Assent is given by a child aged >=12, in addition to the consent of their parent or guardian.
boolean
C1879749 (UMLS CUI [1,1])
C0008059 (UMLS CUI [1,2])
C0008059 (UMLS CUI [1,2])
severe/complicated falciparum malaria
Item
The subject has features of severe/complicated falciparum malaria
boolean
C0032150 (UMLS CUI [1,1])
C0231242 (UMLS CUI [1,2])
C0231242 (UMLS CUI [1,2])
Hypersensitivity to investigational products.
Item
Hypersensitivity to active substances (chlorproguanil, dapsone, artesunate, artemether, lumefantrine), or excipients of the investigational products.
text
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
allergy
Item
Known allergy to biguanides, sulphones, sulphonamides, artemisinin derived products or aminoalcohol drugs.
boolean
C0020517 (UMLS CUI [1,1])
C0013182 (UMLS CUI [1,2])
C0013182 (UMLS CUI [1,2])
Known history of G6PD deficiency, methaemoglobin reductase deficiency, haemoglobin M or E, or porphyria.
Item
Known history of G6PD deficiency, methaemoglobin reductase deficiency, haemoglobin M or E, or porphyria.
boolean
C2939465 (UMLS CUI [1,1])
C0472786 (UMLS CUI [1,2])
C0019030 (UMLS CUI [1,3])
C0019024 (UMLS CUI [1,4])
C3463940 (UMLS CUI [1,5])
C0472786 (UMLS CUI [1,2])
C0019030 (UMLS CUI [1,3])
C0019024 (UMLS CUI [1,4])
C3463940 (UMLS CUI [1,5])
Infants with a history of hyperbilirubinaemia during the neonatal period.
Item
Infants with a history of hyperbilirubinaemia during the neonatal period.
boolean
C0935562 (UMLS CUI [1,1])
C0020433 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0020433 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Use of concomitant medications that may induce haemolysis or haemolytic anaemia from the WHO list of essential drugs.
Item
Use of concomitant medications that may induce haemolysis or haemolytic anaemia from the WHO list of essential drugs.
boolean
C2347852 (UMLS CUI [1,1])
C0002878 (UMLS CUI [1,2])
C0019054 (UMLS CUI [1,3])
C0002878 (UMLS CUI [1,2])
C0019054 (UMLS CUI [1,3])
concomitant infection at the time of presentation
Item
Evidence of any concomitant infection at the time of presentation (including P. vivax, P.ovale and P.malariae).
boolean
C2729427 (UMLS CUI [1])
disease that may compromise the diagnosis and the evaluation of the response to the study medication
Item
Any other underlying disease that may compromise the diagnosis and the evaluation of the response to the study medication (including clinical symptoms of immunosuppression, tuberculosis, bacterial infection; cardiac or pulmonary disease).
boolean
C0679838 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
C0009488 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
Malnutrition
Item
Malnutrition, defined as a child whose weight-for-height is below -3 standard deviation or less than 70% of the median of the NCHS/WHO normalised reference values
boolean
C0162429 (UMLS CUI [1])
Treatment with other drugs
Item
Treatment within the past 3 months with mefloquine or mefloquine-sulphadoxine-pyrimethamine; twenty-eight days with sulphadoxine/pyrimethamine, sulfalene/pyrimethamine, lumefantrine or artemether/lumefantrine, amodiaquine, chloroquinel/dapsone, or 7 days with quinine (full course), proguanil, artemisinins, tetracycline doxycycline or clindamycin.
boolean
C0039798 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
urine screen for ’unknown’ antimalarial drug
Item
Positive sulphadoxine/pyrimethamine urine screen for ’unknown’ antimalarial drug use in prior 28 days.
boolean
C0202274 (UMLS CUI [1,1])
C3653083 (UMLS CUI [1,2])
C3653083 (UMLS CUI [1,2])
Use of an investigational drug within 30 days
Item
Use of an investigational drug within 30 days or 5 half-lives whichever is the longer
boolean
C0013230 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Previous participation in this study.
Item
Previous participation in this study.
boolean
C2348568 (UMLS CUI [1])
child-bearing age, who have had a positive pregnancy
Item
Female subjects of child-bearing age, who have had a positive pregnancy test at screening, or do not give their consent to take a pregnancy test
boolean
C0240802 (UMLS CUI [1])
C1960468 (UMLS CUI [2])
C1960468 (UMLS CUI [2])
Female subjects who will be breast-feeding an infant for the duration of the study
Item
Female subjects who will be breast-feeding an infant for the duration of the study
boolean
C0006147 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Item
Temperature Location
integer
C2826699 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,2])
CL Item
Axilla (3)
CL Item
Tympanic (4)
Item Group
MALARIA PARASITOLOGY - SINGLE ASSESSMENT PRE DOSE
C3661511 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI-2)
Sample Time
Item
Sample Time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
Item Group
MALARIA PARASITOLOGY - SINGLE ASSESSMENT PRE DOSE
C3661511 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI-2)
CL Item
P. falciparum (1)
CL Item
P. vivax (2)
CL Item
P. ovale (3)
CL Item
P. malariae (4)
CL Item
Unknown (5)
CL Item
Positive (POS)
CL Item
Negative (NEG)
Count
Item
Count /UL
text
C0750480 (UMLS CUI [1])
Item Group
GAMETOCYTE - SINGLE ASSESSMENT PRE DOSE
C0686869 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI-2)
CL Item
P. falciparum (1)
CL Item
P. vivax (2)
CL Item
P. ovale (3)
CL Item
P. malariae (4)
CL Item
Unknown (5)
CL Item
Positive (POS)
CL Item
Negative (NEG)
Count
Item
Count /UL
text
C0750480 (UMLS CUI [1])
sample collected for P.F. PCR
Item
Was a sample collected for P.F. PCR?
boolean
C0200345 (UMLS CUI [1,1])
C0032520 (UMLS CUI [1,2])
C0032520 (UMLS CUI [1,2])
Item Group
LABORATORY RESULT DATA (Clinical Chemistry)
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Laboratory Address
Item
Address
text
C3262820 (UMLS CUI [1])
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
ALT Result
Item
ALT Result
text
C0201836 (UMLS CUI [1])
AST Result
Item
AST Result
text
C0201899 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
text
C0201913 (UMLS CUI [1])
Indirect Bilirubin
Item
Indirect Bilirubin
text
C1881193 (UMLS CUI [1])
Creatinine
Item
Creatinine
text
C0201976 (UMLS CUI [1])
Genotype Sample
Item
Has a G6PD Genotype Sample been taken?
boolean
C0017431 (UMLS CUI [1,1])
C0017757 (UMLS CUI [1,2])
C0017757 (UMLS CUI [1,2])
Phenotype Sample
Item
Has a G6PD Phenotype Sample been taken?
boolean
C0031437 (UMLS CUI [1,1])
C0017757 (UMLS CUI [1,2])
C0017757 (UMLS CUI [1,2])
subject able to be randomised
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,2])
If Yes, provide Randomisation number.
Item
If Yes, provide Randomisation number.
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
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