A Randomized Double Blinded Comparison of Ceftazidime and Meropenem in Severe Melioidosis (ATOM)
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ClinicalTrials.gov Identifier: NCT00579956 |
Recruitment Status : Unknown
Verified August 2007 by University of Oxford.
Recruitment status was: Recruiting
First Posted : December 24, 2007
Last Update Posted : June 4, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Melioidosis | Drug: Meropenem Drug: Ceftazidime | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 750 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Double Blinded Comparison of Ceftazidime and Meropenem in Severe Melioidosis |
Study Start Date : | December 2007 |
Estimated Primary Completion Date : | September 2010 |
Estimated Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Meropenem
Meropenem
|
Drug: Meropenem
Meropenem 1gm, diluted with 50ml normal saline solution IV every 8 hours for at least 10 days. The dose will be adjusted according to the creatinine clearance. |
Active Comparator: Ceftazidime
Ceftazidime
|
Drug: Ceftazidime
Ceftazidime 120mg/kg/day divided into 3 equal doses (maximum dose 2 gram/dose), diluted with 50ml normal saline solution IV every 8 hours for at least 10 days The dose will be adjusted according to the plasma creatinine level |
- All cause mortality [ Time Frame: In hospital ]
- All cause mortality in patients culture positive for melioidosis [ Time Frame: In hospital ]
- Switch of antimicrobial therapy [ Time Frame: In hospital ]
- Adverse drug reactions [ Time Frame: 1 month ]
- Fever clearance time (time to body temperature of less than 37.5°C for at least 48 hours) [ Time Frame: In hospital ]
- Length of hospital stay [ Time Frame: months ]

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Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria (all criteria must be satisfied)
A. Community acquired sepsis, and melioidosis is suspected:
Suspected melioidosis (12): all of the following are defined as 'clinically probable' melioidosis
- A history of frequent contact with soil or surface water in the endemic area
- At least one of the following risk factors: diabetes mellitus, chronic renal failure or renal calculi, thalassaemia, aplastic anaemia or steroid abuse
- An illness compatible with melioidosis, including the presence of sepsis, acute pneumonia, acute pyelonephritis, septic arthritis, parotid disease or skin or soft tissue infection, or
- An evidence of intra-abdominal suppuration (hepatic or splenic abscesses) regardless of risk factors or exposure history
Sepsis: defined as patients who have Systemic Inflammatory Response Syndrome (SIRS) - two or more of the following, clinically ascribed to infection:
- Fever: temperature >38°C or <36°C
- Tachycardia: heart rate >90 beats/min
-
Tachypnoea:
- Respiratory rate >20 breaths/minute; or
- PaCO2 <32 mmHg; or
- Mechanical ventilation
- White cell count >12,000 cells/mL or <4,000 cells/mL or >10% band forms B. Age > 14 years. C. Need hospitalisation and intravenous antibiotic administration. D. Willingness to participate in the study and written, informed consent obtained from the patient.
Exclusion Criteria (any one of the following):
A. Pregnant or lactating women. B. Known hypersensitivity to meropenem or ceftazidime. C. Previous isolate with known resistance to ceftazidime or meropenem. D. Patients not expected to remain in hospital for treatment. E. Patients with community-acquired sepsis with cultures positive for other organisms.
F. Patients treated with antibiotics active against B. pseudomallei (including ceftazidime, amoxicillin-clavulanate, meropenem) for this episode for greater than 24 hours.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579956
Contact: Wirongrong Chierakul, MD | 6689 1058571 | kae@tropmedres.ac |
Thailand | |
Sappasithiprasong Hospital | Recruiting |
Ubonratchathani, Ubon, Thailand | |
Contact: Direk Limmathurotsakul, MD 6681 6149551 direk@tropmedres.ac | |
Udon Thani General Hospital | Recruiting |
Udon Thani, Thailand | |
Contact: Prapit Teparakkul, MD 6681 8779864 |
Principal Investigator: | Wirongrong Chierakul, MD | Mahidol University |
Responsible Party: | Nick Day, Oxford University |
ClinicalTrials.gov Identifier: | NCT00579956 |
Other Study ID Numbers: |
OXTREC 018-06 |
First Posted: | December 24, 2007 Key Record Dates |
Last Update Posted: | June 4, 2008 |
Last Verified: | August 2007 |
Melioidosis Burkholderia Infections Gram-Negative Bacterial Infections Bacterial Infections |
Meropenem Ceftazidime Anti-Bacterial Agents Anti-Infective Agents |