- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03074656
The Norwegian Drug Monitoring Study (NOR-DRUM)
A NORwegian Multicentre Randomised Controlled Trial Assessing the Effectiveness of Tailoring Infliximab Treatment by Therapeutic DRUg Monitoring - The NOR-DRUM Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Arendal, Norway
- Sørlandet Sykehus, Arendal
-
Bergen, Norway
- Haukeland, HELSE BERGEN HF,
-
Bodø, Norway
- Bodø, NORDLANDSSYKEHUSET
-
Drammen, Norway
- Drammen, VESTRE VIKEN HF
-
Elverum, Norway
- Elverum, SYKEHUSET INNLANDET HF
-
Førde, Norway
- Helse Førde HF
-
Hamar, Norway
- Hamar, SYKEHUSET INNLANDET HF
-
Haugesund, Norway
- HAUGESUND SANITETSFORENING revmatismesykehus
-
Haugesund, Norway
- Haugesund Sjukehus
-
Kristiansand, Norway
- Sørlandet sykehus HF Kristiansand
-
Lillehammer, Norway
- REVMATISMESYKEHUSET AS, Lillehammer
-
Moss, Norway, 1535
- Sykehuset Østfold Moss
-
Oslo, Norway, 0372
- Rikshospitalet
-
Oslo, Norway, 0687
- Diakonhjemmet Sykehus
-
Skien, Norway
- Betanien Hospital
-
Stavanger, Norway
- Stavanger Universitetssjukehus
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Tromsø, Norway
- Tromsø, UNIVERSITETSSYKEHUSET NORD-NORGE HF
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Trondheim, Norway
- St Olavs Hospital
-
Tønsberg, Norway
- Sykehuset Vestfold, Tønsberg
-
Ålesund, Norway
- Ålesund, HELSE MØRE OG ROMSDAL HF
-
-
Lørenskog
-
Oslo, Lørenskog, Norway, 1478
- Akershus University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
NOR-DRUM A
- A clinical diagnosis of one of the following; rheumatoid arthritis, spondyloarthritis (including ankylosing spondylitis), psoriatic arthritis*, ulcerative colitis, Crohn's disease or chronic plaque psoriasis
- Male or non-pregnant female
- ≥18 and < 75 years of age at screening
- A clinical indication to start INX
- Subject not in remission according to diagnosis-specific disease activity scores
Subject capable of understanding and signing an informed consent form
- Patients with psoriatic arthritis with predominantly axial manifestations should be included and assessed as spondyloarthritis
NOR-DRUM B
- A clinical diagnosis of one of the following; rheumatoid arthritis, spondyloarthritis (including ankylosing spondylitis), psoriatic arthritis*, ulcerative colitis, Crohn's disease or chronic plaque psoriasis
- Male or non-pregnant female
- ≥18 and < 75 years of age at screening
- On maintenance therapy with infliximab for a minimum of 30 weeks and a maximum of 3 years
- A clinical indication for further infliximab treatment
Subject capable of understanding and signing an informed consent form
- Patients with psoriatic arthritis and predominantly axial manifestations should be included and assessed as spondyloarthritis
Exclusion Criteria:
NOR-DRUM A
- Major co-morbidities, such as previous malignancies within the last 5 years, severe diabetes mellitus, severe infections (including HIV), uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratory diseases, demyelinating disease, significant chronic widespread pain syndrome, laboratory abnormalities or significant renal or hepatic disease and/or other diseases or conditions where treatment with infliximab is either found contra-indicated by the clinician or which make adherence to the protocol difficult
- A positive screening for TB and hepatitis
- Inadequate birth control, pregnancy or subject considering becoming pregnant during the study period
- Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult
- Prior use of infliximab within the last 6 months
NOR-DRUM B
- Major co-morbidities, such as previous malignancies within the last 5 years, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratory diseases, demyelinating disease, significant chronic widespread pain syndrome, laboratory abnormalities or significant renal or hepatic disease and/or other diseases or conditions where treatment with infliximab is either found contra-indicated by the clinician or which make adherence to the protocol difficult
- Inadequate birth control, pregnancy or subject considering becoming pregnant during the study period
- Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Therapeutic drug monitoring
Administration of infliximab according to a treatment strategy based on therapeutic drug monitoring and assessments of anti-drug antibodies
|
Treatment algorithm based on assessments of serum drug levels and anti-drug antibodies
|
ACTIVE_COMPARATOR: Standard care
Administration of infliximab according to standard clinical care, without knowledge of drug levels or status of anti-drug antibodies
|
Treatment algorithm based on standard clinical assessments, without knowledge of serum drug levels and anti-drug antibodies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients in remission defined by disease specific composite scores Study part A
Time Frame: 30 weeks
|
Definition of remission: DAS 28 score <2.6 in patients with RA and PsA, ASDAS score <1.3 in patients with SpA, Mayo score of ≤2 with no sub scores >1 in patients with UC, HBI score of ≤4 in CD and PASI score of ≤4 in patients with Ps.
|
30 weeks
|
Sustained disease control throughout the study period without disease worsening defined by disease specific composite scores Study part B
Time Frame: 52 weeks
|
Definition of disease worsening: RA/PsA: Change DAS28 of ≥ 1.2 and min DAS 3.2 SpA: Increase in ASDAS of ≥1.1 and min ASDAS of 2.1 UC: Increase in Partial Mayo score of ≥ 3 and min score of ≥ 5 CD: Increase in HBI of ≥ 4 points and min score of 7 Ps: Increase in PASI of ≥ 3 points and min PASI score of 5 Or: Patient and investigator consensus on disease worsening
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to sustained remission (Part A)
Time Frame: Assessed at all time points up to 30 weeks
|
Remission at all following visit
|
Assessed at all time points up to 30 weeks
|
Patient's and physician's global assessment of disease activity (Part A and B)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
Visual analogue scale (VAS) 0 mm-100 mm (100 mm worst outcome)
|
30 weeks (A) and 52 weeks (B)
|
ESR (Part A and B)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
0-100 mmHg
|
30 weeks (A) and 52 weeks (B)
|
CRP (Part A and B)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
mg/L
|
30 weeks (A) and 52 weeks (B)
|
Occurrence of anti-drug antibodies (Part A and B)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
Defined as ADAb ≥15 µg/L
|
30 weeks (A) and 52 weeks (B)
|
Occurrence of drug discontinuation (Part A and B)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
Infliximab discontinuation
|
30 weeks (A) and 52 weeks (B)
|
Cost effectiveness, QALY
Time Frame: 30 weeks (A) and 52 weeks (B)
|
Part A and B (Incremental Quality adjusted life years (QALYs) of the intervention arm and active comparator)
|
30 weeks (A) and 52 weeks (B)
|
Cost effectiveness, ICERs
Time Frame: 30 weeks (A) and 52 weeks (B)
|
Part A and B (Cost-effectiveness ratios (ICERs) of the intervention arm and active comparator)
|
30 weeks (A) and 52 weeks (B)
|
Health utility (EQ-5D)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
EuroQol 5 (EQ-5D) dimensions The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions.
This decision results in a 1-digit number that expresses the level selected for that dimension.
The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state
|
30 weeks (A) and 52 weeks (B)
|
Quality of life (SF-36)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
The SF-36 is a multi-purpose, short-form health survey with 36 questions.
The SF-36 will be scored according to RAND 36-Item Health Survey 1.0 to form eight measures scores 0-100 (100 worst outcome): physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.
|
30 weeks (A) and 52 weeks (B)
|
Safety (adverse events frequency)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
A and B
|
30 weeks (A) and 52 weeks (B)
|
Time to disease worsening
Time Frame: 52 weeks
|
Part B
|
52 weeks
|
Proportion of patients in remission, diagnostic subgroups (overall in B)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
RA/PsA: DAS28 remission, SDAI remission, ACR/EULAR remission, SpA: ASDAS inactive disease, UC: PMS, CD: HBI, Ps PASI
|
30 weeks (A) and 52 weeks (B)
|
Serum drug level
Time Frame: Assessed at all time points up to 30 weeks
|
Trough level
|
Assessed at all time points up to 30 weeks
|
Proportion of patients with improvement defined by disease specific composite scores (Part A)
Time Frame: 14 weeks
|
|
14 weeks
|
Time to remission (Part A)
Time Frame: Assessed at all time points up to week 30
|
Definition of remission: DAS 28 score <2.6 in patients with RA and PsA, ASDAS score <1.3 in patients with SpA, Mayo score of ≤2 with no sub scores >1 in patients with UC, HBI score of ≤4 in CD and PASI score of ≤4 in patients with Ps.
|
Assessed at all time points up to week 30
|
DAS28 (RA and PsA only)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
The 28-joint Disease Activity Score (DAS28) includes the 28- tender joint counts (TJC28), 28-swollen joint counts (SJC28), Erythrocyte Sedimentation Rate (ESR) and Patient Global Assessment (PGA) on a VAS According to DAS28, the following cut-points are used: High disease activity: DAS28 > 5.1 Moderate disease activity: 5.1 ≥ DAS28>3.2 Low disease activity: 3.2 ≥ DAS28 ≥ 2.6 In remission: DAS28 < 2.6 |
30 weeks (A) and 52 weeks (B)
|
Partial Mayo score
Time Frame: 30 weeks (A) and 52 weeks (B)
|
The Mayo score consists of four components (rectal bleeding, stool frequency, physician rating of disease activity, and mucosal appearance at endoscopy) rated from 0-3 that are summed to give a total score that ranges from 0-12. The non-invasive partial Mayo score (PMS) does not require an endoscopy, and thereby ranging from 0-9. Remission is defined as a partial Mayo score of ≤ 2 with no individual subscore >1 |
30 weeks (A) and 52 weeks (B)
|
SDAI (RA and PsA only)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
The Simplified Disease Activity Index (SDAI) includes TCJ28, SJC28, PGA, PhGA and CRP.
In remission: SDAI ≤ 3.3.
High values denotes worse outcomes.
High values denotes worse outcomes.
|
30 weeks (A) and 52 weeks (B)
|
EULAR response (RA and PsA only)
Time Frame: 30 weeks (A)
|
Defined according to EULAR definition
|
30 weeks (A)
|
ACR/EULAR remission
Time Frame: 30 weeks (A)
|
|
30 weeks (A)
|
ACR response
Time Frame: 30 weeks (A)
|
If a patient experiences a flare and treatment is escalated, the ACR response rates ACR20, ACR50, ACR70 and ACR90 as well as ACR remission rates will be calculated. An ACR20 response is defined if the following criteria are fulfilled:
The other core set items consist of:
|
30 weeks (A)
|
DAPSA (PsA only)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
Disease Activity index for PSoriatic Arthritis (DAPSA) is calculated as follows: TJC68 + SJC66 + CRP(mg/L)/10 + PGA(0-100)/10+VAS Pain(0-100)/10.
High values denotes worse outcomes.
|
30 weeks (A) and 52 weeks (B)
|
BASDAI (SpA only)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
The Bath Ankylosing Spondylitits Disease Activity Index (BASDAI) includes six questions pertaining to the five major symptoms of ankylosing spondylitis: fatigue (Q1), spinal pain (Q2), joint pain/swelling (Q3), areas of localized tenderness (Q4), morning stiffness duration (Q5) and morning stiffness severity (Q6).
Each question is scored on an NRS (0-10).
|
30 weeks (A) and 52 weeks (B)
|
ASDAS
Time Frame: 30 weeks (A) and 52 weeks (B)
|
The Ankylosing Spondylitis Disease Activity Score (ASDAS) is computed based on patient reported outcomes (components of BASDAI) and the CRP. The ASDAS-CRP is calculated as follows: ASDAS-CRP=0.121*total back pain + 0.0110*patient global + 0.073*peripheral pain/swelling + 0.058*duration of morning stiffness + 0.579*ln(CRP+1 High values denotes worse outcomes |
30 weeks (A) and 52 weeks (B)
|
Partial Mayo Score (UC only)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
The Mayo score consists of four components (rectal bleeding, stool frequency, physician rating of disease activity, and mucosal appearance at endoscopy) rated from 0-3 that are summed to give a total score that ranges from 0-12. The non-invasive partial Mayo score (PMS) does not require an endoscopy, and thereby ranging from 0-9. Remission is defined as a partial Mayo score of ≤ 2 with no individual subscore >1 |
30 weeks (A) and 52 weeks (B)
|
Harvey-Bradshaw Index (CD only)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
The Harvey-Bradshaw index (HBI) consists of five domains, general well-being (0-4), abdominal pain (0-3), number of liquid soft stools per day, abdominal mass (0-3) and number of predefined complications. The scores of each sub-domain is summed up to compute the HBI. Remission is defined as a HBI score ≤ 4 points. |
30 weeks (A) and 52 weeks (B)
|
Psoriasis Area and Severity Index (PASI) (Ps only)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
A PASI 50/75 means a 50% /75% reduction in the PASI score. Complete clearance is defined as PASI=0, mild to moderate psoriasis is defined as PASI < 10, moderate to severe psoriasis between 10 and 20 and severe psoriasis above 20. Remission is defined as PASI <4 |
30 weeks (A) and 52 weeks (B)
|
Modified Health Assessment Questionnaire
Time Frame: 30 weeks (A) and 52 weeks (B)
|
Each item of the Modified Health Assessment Questionnaire (MHAQ) is scored on a categorical 0-3 scale and the sum score is divided by 8 to form the MHAQ score 0.0 to 3.0 (3.0 worst outcome possible)
|
30 weeks (A) and 52 weeks (B)
|
Rheumatoid Arthritis Impact of Disease (RA only)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
The Rheumatoid Arthritis Impact of Disease (RAID) score is calculated based on seven numerical rating scales (NRS) questions.
Each NRS is assessed as a number between 0 and 10.
The seven NRS correspond to pain, function, fatigue, sleep, emotional wellbeing, physical wellbeing and coping/self-efficacy.
|
30 weeks (A) and 52 weeks (B)
|
Psoriatic Arthritis Impact of Disease (PsAID) score
Time Frame: 30 weeks (A) and 52 weeks (B)
|
Psoriatic Arthritis Impact of Disease (PsAID) score is a questionnaire with 9 domains of health.
The nine domains with relative weights are: pain (0.174), fatigue (0.131), skin (0.121), work and/or leisure activities (0.110), function (0.107), discomfort (0.098), sleep (0.089), coping (0.087) and anxiety (0.085), each rated on an NRS (0-10).
The rates of each domain are weighted and summed to form a score in the range of 0-10 (10 worst outcome possible).
The final RAID score is computed.
The scale 0-10 where higher figures indicate worse status.
|
30 weeks (A) and 52 weeks (B)
|
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
The Inflammatory Bowel Disease Questionnaire (IBDQ) is widely used tool to measure health-related quality of life in patients with inflammatory bowel diseases.
The questionnaire consists of 32 questions scored in four domains: bowel symptoms, emotional health, systemic systems and social function.
The total IBDQ score is the sum of all the question scores, ranging 32 to 224 (224 worst possible)
|
30 weeks (A) and 52 weeks (B)
|
Total drug consumption
Time Frame: 30 weeks (A) and 52 weeks (B)
|
mg/kg/ week
|
30 weeks (A) and 52 weeks (B)
|
Dermatology Life Quality Index (DLQI)
Time Frame: 30 weeks (A) and 52 weeks (B)
|
The Dermatology Life Quality Index (DLQI) consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week.
It has been validated for adult dermatology patients aged 16 years and older.
The items of the DLQI encompass aspects of symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment.
Each question is scored on a 4-point Likert scale: Not at all/Not relevant=0, A little=1, A lot=2 and Very much=3.
Scores of individual items (0-3) are added to yield a total score (0-30); higher scores mean greater impairment of patient's QoL.
The DLQI will only be presented to patients with chronic plaque psoriasis.
|
30 weeks (A) and 52 weeks (B)
|
Calprotectin
Time Frame: 30 weeks (A) and 52 weeks (B)
|
Faecal calprotectin is an inflammatory marker for IBD.
It is measured in mg/kg
|
30 weeks (A) and 52 weeks (B)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Espen A Haavardsholm, MD, PhD, Diakonhjemmet Hospital
- Study Director: Tore K Kvien, MD, PhD, Diakonhjemmet Hospital
Publications and helpful links
General Publications
- Syversen SW, Jorgensen KK, Goll GL, Brun MK, Sandanger O, Bjorlykke KH, Sexton J, Olsen IC, Gehin JE, Warren DJ, Klaasen RA, Noraberg G, Bruun TJ, Dotterud CK, Ljosa MKA, Haugen AJ, Njalla RJ, Zettel C, Ystrom CM, Bragnes YH, Skorpe S, Thune T, Seeberg KA, Michelsen B, Blomgren IM, Strand EK, Mielnik P, Torp R, Mork C, Kvien TK, Jahnsen J, Bolstad N, Haavardsholm EA. Effect of Therapeutic Drug Monitoring vs Standard Therapy During Maintenance Infliximab Therapy on Disease Control in Patients With Immune-Mediated Inflammatory Diseases: A Randomized Clinical Trial. JAMA. 2021 Dec 21;326(23):2375-2384. doi: 10.1001/jama.2021.21316.
- Syversen SW, Goll GL, Jorgensen KK, Sandanger O, Sexton J, Olsen IC, Gehin JE, Warren DJ, Brun MK, Klaasen RA, Karlsen LN, Noraberg G, Zettel C, Ljosa MKA, Haugen AJ, Njalla RJ, Bruun TJ, Seeberg KA, Michelsen B, Strand EK, Skorpe S, Blomgren IM, Bragnes YH, Dotterud CK, Thune T, Ystrom CM, Torp R, Mielnik P, Mork C, Kvien TK, Jahnsen J, Bolstad N, Haavardsholm EA. Effect of Therapeutic Drug Monitoring vs Standard Therapy During Infliximab Induction on Disease Remission in Patients With Chronic Immune-Mediated Inflammatory Diseases: A Randomized Clinical Trial. JAMA. 2021 May 4;325(17):1744-1754. doi: 10.1001/jama.2021.4172.
- Syversen SW, Goll GL, Jorgensen KK, Olsen IC, Sandanger O, Gehin JE, Warren DJ, Sexton J, Mork C, Jahnsen J, Kvien TK, Bolstad N, Haavardsholm EA. Therapeutic drug monitoring of infliximab compared to standard clinical treatment with infliximab: study protocol for a randomised, controlled, open, parallel-group, phase IV study (the NOR-DRUM study). Trials. 2020 Jan 6;21(1):13. doi: 10.1186/s13063-019-3734-4.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Infections
- Gastrointestinal Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Gastroenteritis
- Intestinal Diseases
- Skin Diseases, Papulosquamous
- Spinal Diseases
- Bone Diseases
- Inflammatory Bowel Diseases
- Spondylarthropathies
- Bone Diseases, Infectious
- Ankylosis
- Arthritis
- Psoriasis
- Crohn Disease
- Arthritis, Psoriatic
- Spondylitis
- Spondylarthritis
- Spondylitis, Ankylosing
Other Study ID Numbers
- DIA2016-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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