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The aim of this study is to impove the pharmacological treatment of Rocky mountain spotted fever, since is a very ancient disease with an antibiotic therapy that have not changed much the mortality rates, being compared with the natural curse of the disease.
Rocky mountain spotted fever is a potentially fatal infectious disease wich is transmitted trough vectors. This particular infection is caused by Rickettsia rickettsii wich is a gramnegative intracellular bacilli. The pathophysiological mechanism and clinical manifestation is mainly due to the vascular affectation, since this pathogen has a tropism for endothelial cells. As it has been mentioned, this is an obligate intracellular pathogen, so the main choice with the antibiotic therapy is tetracyclines because of its action mechanism in the inhibition of the subunit 30S. The objective of the study is to prove new strategies of treatment to improve the pharmacological aproach by implementing Azithromycin, wich is a macrolide that inhibits de 50S subunit of the bacteria. Azithromycin has shown effectivity against other rickettsial diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Azithromycine group |
|
| B | Placebo Comparator | Placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin + Doxycycline | Drug | azithromycin 500 mg orally every 24 hours for three dose plus doxycycline 100 mg orally every 12 hours for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality of azithromycin plus doxycycline vs doxycycline plus placebo | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hospitalization days in each arm | 3 years | |
| Number of participants with renal replacement therapy. | 3 years | |
| Number of participants that required amines in both groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hiram J. Jaramillo-Ramirez, MD | Contact | 686 135 8412 | grupoinvestigacionmedica@gmail.com | |
| Gisel V. Licon-Martinez, MD | Contact | 686 194 5903 | viviana.licon@uabc.edu.mx |
| Name | Affiliation | Role |
|---|---|---|
| Hiram J Jaramillo-Ramirez, MD | Hospital General de Mexicali | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Mexicali | Recruiting | Mexicali | Estado de Baja California | 21000 | Mexico |
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| ID | Term |
|---|---|
| D012373 | Rocky Mountain Spotted Fever |
| ID | Term |
|---|---|
| D000073605 | Spotted Fever Group Rickettsiosis |
| D012282 | Rickettsia Infections |
| D012288 | Rickettsiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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Controlled randomized trial with placebo, triple blinded, multicenter study
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Patients will be randomized through the program ¨Randomizer for Clinical Trial¨ to be assigned in group of treatment A or B. One of the treatments will be azithromycin 500 mg orally every 24 hours for three dose plus doxycycline 100 mg orally every 12 hours for 7 days and the other schedule it will be doxycycline 100 mg orally every 12 hours for 7 days plus placebo 1 capsule every 24 hours, 3 doses.
| Placebo + Doxycycline | Drug | doxycycline 100 mg orally every 12 hours for 7 days plus placebo 1 capsule every 24 hours, 3 doses |
|
|
| 3 years |
| Number of fever days in both arms. | 3 years |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| Organic Chemicals |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |