Trial Outcomes & Findings for Anaemetro I.V. Infusion 500mg Drug Use Investigation (NCT NCT03491228)

Last Updated: 2018-12-28

Results Overview

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to ANAEMETRO Intravenous infusion in a participant who received ANAEMETRO Intravenous infusion. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to ANAEMETRO Intravenous infusion was assessed by the physician.

Recruitment status

COMPLETED

Target enrollment

107 participants

Primary outcome timeframe

Maximum 8 weeks

Results posted on

2018-12-28

Participant Flow

Participant milestones

Participant milestones
Measure	ANAEMETRO Intravenous Infusion (Metronidazole) Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician's discretion.
Overall Study STARTED	107
Overall Study COMPLETED	107
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ANAEMETRO Intravenous Infusion (Metronidazole) n=107 Participants Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician's discretion.
Age, Customized <15 years	0 Participants n=107 Participants
Age, Customized ≥15 and <65 years	40 Participants n=107 Participants
Age, Customized ≥65 years	67 Participants n=107 Participants
Sex/Gender, Customized Male	69 Participants n=107 Participants
Sex/Gender, Customized Female	38 Participants n=107 Participants
Target Diseases Anaerobic infection	74 Participants n=107 Participants
Target Diseases Infectious enterocolitis	23 Participants n=107 Participants
Target Diseases Amebic dysentery	7 Participants n=107 Participants
Target Diseases Infectious enterocolitis + amebic dysentery	3 Participants n=107 Participants

PRIMARY outcome

Timeframe: Maximum 8 weeks

Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received ANAEMETRO Intravenous infusion at least once.

Outcome measures

Outcome measures
Measure	ANAEMETRO Intravenous Infusion (Metronidazole) n=107 Participants Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician's discretion.
Number of Participants With Adverse Drug Reaction (ADR) ADR	7 Participants
Number of Participants With Adverse Drug Reaction (ADR) Serious ADR	1 Participants

SECONDARY outcome

Timeframe: Maximum 8 weeks

Population: The clinical efficacy analysis set comprised of participants from the safety analysis set, excluding those with no information of clinical response or infections other than target disease. Participants evaluated as "indeterminate (n=12)" were excluded from the calculation.

Outcome measures

Outcome measures
Measure	ANAEMETRO Intravenous Infusion (Metronidazole) n=95 Participants Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician's discretion.
Clinical Response Rate	95.8 Percentage of Participants Interval 89.6 to 98.8

SECONDARY outcome

Timeframe: Maximum 8 weeks

Clinical response of ANAEMETRO Intravenous infusion was evaluated comprehensively at the completion of the observation period, being assessed as "effective," "not effective," or "indeterminate" by the physician based on clinical symptoms. Clinical response rate, which was defined as the percentage of participants evaluated as "effective" over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Participants assessed as "effective" by the following target diseases were counted to assess whether they contribute to the clinical response: anaerobic infection, infectious enterocolitis, amebic dysentery, and the infection with both infectious enterocolitis and amebic dysentery.

Outcome measures

Outcome measures
Measure	ANAEMETRO Intravenous Infusion (Metronidazole) n=95 Participants Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician's discretion.
Clinical Response Rates by Target Diseases Anaerobic infection (n=64)excluding IND(n=10)	93.8 Percentage of Participants Interval 84.8 to 98.3
Clinical Response Rates by Target Diseases Infectious enterocolitis (n=21) excluding IND(n=2)	100.0 Percentage of Participants Interval 83.9 to 100.0
Clinical Response Rates by Target Diseases Amebic dysentery (n=7)	100.0 Percentage of Participants Interval 59.0 to 100.0
Clinical Response Rates by Target Diseases Infectious enterocolitis + amebic dysentery (n=3)	100.0 Percentage of Participants Interval 29.2 to 100.0

Adverse Events

ANAEMETRO Intravenous Infusion (Metronidazole)

Serious events: 11 serious events

Other events: 2 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	ANAEMETRO Intravenous Infusion (Metronidazole) n=107 participants at risk Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician's discretion.
Infections and infestations Bronchopulmonary aspergillosis	0.93% 1/107 • Maximum 8 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Clostridium difficile infection	0.93% 1/107 • Maximum 8 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Pneumonia	0.93% 1/107 • Maximum 8 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Blood and lymphatic system disorders Disseminated intravascular coagulation	1.9% 2/107 • Maximum 8 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.93% 1/107 • Maximum 8 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.93% 1/107 • Maximum 8 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Cholecystitis acute	0.93% 1/107 • Maximum 8 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Liver disorder	1.9% 2/107 • Maximum 8 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
General disorders Multiple organ dysfunction syndrome	0.93% 1/107 • Maximum 8 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.

Other adverse events

Other adverse events
Measure	ANAEMETRO Intravenous Infusion (Metronidazole) n=107 participants at risk Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician's discretion.
Nervous system disorders Nausea	1.9% 2/107 • Maximum 8 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER