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Last Updated: September 23, 2021

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CLINICAL TRIALS PROFILE FOR GENTAMICIN

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505(b)(2) Clinical Trials for Gentamicin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00244777 ↗ Introduction of Hypo-osmolar ORS for Routine Use Completed United States Agency for International Development (USAID) Phase 4 2002-12-01 The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
New Formulation NCT00244777 ↗ Introduction of Hypo-osmolar ORS for Routine Use Completed International Centre for Diarrhoeal Disease Research, Bangladesh Phase 4 2002-12-01 The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Gentamicin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00005574 ↗ Gentamicin Treatment of Muscular Dystrophy Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 1 2000-02-01 This study will evaluate the antibiotic gentamicin for treating patients with muscular dystrophy caused by a specific genetic abnormality known as a nonsense mutation. In studies of mice with this type of muscular dystrophy, gentamicin treatment produced positive changes in muscle tissue. Patients with Duchenne or Becker muscular dystrophy caused by nonsense mutations by may be eligible for this 2-week study. Before starting treatment, patients will have evaluations of muscle strength and general well being. Two muscle tissue samples will be taken by needle biopsy, under local anesthetic and sedation. Because of potential risks of hearing loss and kidney toxicity associated with gentamicin, patients will also have a hearing test and blood and urine tests for kidney function before starting treatment. (Currently, gentamicin is commonly prescribed for serious infections of the lungs, heart, and digestive and urinary tracts; adverse effects of hearing loss and kidney toxicity can occur with excessively high drug doses.) Patients will be hospitalized during drug treatment. Gentamicin will be given intravenously (through a vein) once a day for 14 days. Blood samples will be collected daily to monitor drug levels and determine dosage adjustments, if necessary. Urine samples will be collected to assess kidney function. Hearing tests will be done on days 7 and 10. On the last day of the study, hearing, kidney function, and muscle strength will be tested and the results compared with pre-treatment levels. Blood and muscle samples will also be taken again for pre-treatment comparison. Hearing, blood, urine, and muscle strength tests will be repeated one month after treatment ends for comparison with previous results.
NCT00093067 ↗ Daptomycin in the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to S. Aureus Completed Cubist Pharmaceuticals LLC Phase 3 2002-03-01 The purpose of this study is to compare the safety and efficacy of daptomycin, an antibiotic, to standard therapy in subjects who have infective endocarditis or bacteremia due to Staphylococcus aureus (S. aureus).
NCT00128466 ↗ Treatment and Diagnosis of Plague Completed Food and Drug Administration (FDA) Phase 2/Phase 3 2004-08-01 This clinical trial will compare the effectiveness of streptomycin, which historically is the standard drug for treatment of plague, with gentamicin. The hypothesis is that gentamicin is not inferior to streptomycin but that it will have less severe side effects. The study is being done in Madagascar because that country reports the most plague cases in the world. Patients coming into a participating clinic with suspected plague (bubonic, pneumonic, or septicemic) will be randomized into one of two treatment arms after giving informed consent. Patients will be monitored for side effects and for improvement of symptoms. In addition, rapid diagnostic test strips have been developed but not fully evaluated for use on humans. The investigators will evaluate these new tests on specimens from the same patients, comparing their performance with that of classical diagnostic methods such as culture and serology.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Gentamicin

Condition Name

Condition Name for Gentamicin
Intervention Trials
Infection 8
Cutaneous Leishmaniasis 6
Sepsis 5
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Condition MeSH

Condition MeSH for Gentamicin
Intervention Trials
Infection 28
Communicable Diseases 18
Leishmaniasis, Cutaneous 11
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Clinical Trial Locations for Gentamicin

Trials by Country

Trials by Country for Gentamicin
Location Trials
United States 165
Germany 10
India 9
Canada 9
Spain 8
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Trials by US State

Trials by US State for Gentamicin
Location Trials
California 16
Maryland 11
Florida 9
Ohio 9
Pennsylvania 8
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Clinical Trial Progress for Gentamicin

Clinical Trial Phase

Clinical Trial Phase for Gentamicin
Clinical Trial Phase Trials
Phase 4 36
Phase 3 26
Phase 2/Phase 3 10
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Clinical Trial Status

Clinical Trial Status for Gentamicin
Clinical Trial Phase Trials
Completed 47
Recruiting 32
Not yet recruiting 23
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Clinical Trial Sponsors for Gentamicin

Sponsor Name

Sponsor Name for Gentamicin
Sponsor Trials
U.S. Army Medical Research and Materiel Command 11
Innocoll 7
Premier Research Group plc 5
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Sponsor Type

Sponsor Type for Gentamicin
Sponsor Trials
Other 182
Industry 25
U.S. Fed 22
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