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Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections

Information source: Abbott
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mycobacterium Infections, Atypical

Phase: N/A

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Jun Kato, MD., Ph.D., Study Director, Affiliation: Abbott Japan Co.,Ltd

Summary

To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.

Clinical Details

Official title: Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Evaluation of adverse event (occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Klaricid)

Rate of bacterial eradication

Secondary outcome: Efficacy Evaluation using the 4-rank scale of "effective", "ineffective", "harmful", or "impossible" by the investigator

Eligibility

Minimum age: 15 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria

- Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated

for treatment with Klaricid Exclusion Criteria

- Contraindications according to the package insert

- Patients with a history of hypersensitivity to any ingredient of Klaricid

- Patients who are receiving pimozide, ergot-containing products, or cisapride

- Patients who have AIDS (Acquired Immune Deficiency Syndrome)

Locations and Contacts

Site Reference ID/Investigator# 36460, Aichi, Japan

Site Reference ID/Investigator# 39122, Aichi, Japan

Site Reference ID/Investigator# 36463, Akita, Japan

Site Reference ID/Investigator# 36470, Ehime, Japan

Site Reference ID/Investigator# 36471, Fukuoka-shi, Japan

Site Reference ID/Investigator# 36472, Fukuoka, Japan

Site Reference ID/Investigator# 36473, Fukushima, Japan

Site Reference ID/Investigator# 36474, Gifu, Japan

Site Reference ID/Investigator# 36475, Hiroshima, Japan

Site Reference ID/Investigator# 36482, Hyogo, Japan

Site Reference ID/Investigator# 36465, Inzai, Japan

Site Reference ID/Investigator# 36483, Ishikawa, Japan

Site Reference ID/Investigator# 36484, Kagoshima, Japan

Site Reference ID/Investigator# 36485, Kanagawa, Japan

Site Reference ID/Investigator# 36486, Kanagawa, Japan

Site Reference ID/Investigator# 36487, Kanagawa, Japan

Site Reference ID/Investigator# 54466, Kitakyushu, Japan

Site Reference ID/Investigator# 54468, Kobe, Japan

Site Reference ID/Investigator# 36488, Kochi, Japan

Site Reference ID/Investigator# 36513, Kofu, Japan

Site Reference ID/Investigator# 39126, Kumamoto, Japan

Site Reference ID/Investigator# 36489, Kyoto, Japan

Site Reference ID/Investigator# 36493, Kyoto, Japan

Site Reference ID/Investigator# 39123, Kyoto, Japan

Site Reference ID/Investigator# 54469, Maebashi, Japan

Site Reference ID/Investigator# 36494, Miyagi, Japan

Site Reference ID/Investigator# 36495, Miyazaki, Japan

Site Reference ID/Investigator# 36459, Nagoya, Japan

Site Reference ID/Investigator# 36461, Nagoya, Japan

Site Reference ID/Investigator# 54465, Nara, Japan

Site Reference ID/Investigator# 37145, Obihiro, Japan

Site Reference ID/Investigator# 36496, Oita, Japan

Site Reference ID/Investigator# 36497, Okayama, Japan

Site Reference ID/Investigator# 39125, Okinawa, Japan

Site Reference ID/Investigator# 28404, Osaka, Japan

Site Reference ID/Investigator# 36492, Osaka, Japan

Site Reference ID/Investigator# 36501, Saitama, Japan

Site Reference ID/Investigator# 54464, Saitama, Japan

Site Reference ID/Investigator# 36477, Sapporo, Japan

Site Reference ID/Investigator# 36478, Sapporo, Japan

Site Reference ID/Investigator# 36481, Sapporo, Japan

Site Reference ID/Investigator# 36462, Seto, Japan

Site Reference ID/Investigator# 36503, Shimane, Japan

Site Reference ID/Investigator# 36506, Shimotsuke, Japan

Site Reference ID/Investigator# 36504, Shizuoka, Japan

Site Reference ID/Investigator# 36505, Shizuoka, Japan

Site Reference ID/Investigator# 36499, Takatsuki, Japan

Site Reference ID/Investigator# 15101, Tokyo, Japan

Site Reference ID/Investigator# 36507, Tokyo, Japan

Site Reference ID/Investigator# 36508, Tokyo, Japan

Site Reference ID/Investigator# 36509, Tokyo, Japan

Site Reference ID/Investigator# 36510, Tokyo, Japan

Site Reference ID/Investigator# 42710, Tokyo, Japan

Site Reference ID/Investigator# 54470, Tokyo, Japan

Site Reference ID/Investigator# 36458, Toyohashi, Japan

Site Reference ID/Investigator# 36511, Wakayama, Japan

Site Reference ID/Investigator# 37144, Wakayama, Japan

Site Reference ID/Investigator# 36512, Yamaguchi, Japan

Site Reference ID/Investigator# 39124, Yamanashi, Japan

Additional Information

Starting date: January 2009
Last updated: May 22, 2014

Page last updated: August 20, 2015

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