CLINDESSE SUMMARY
Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.
Clindesse™ is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in non-pregnant women. There are no adequate and well-controlled studies of Clindesse™ in pregnant women.
Note: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.
Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.
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NEWS HIGHLIGHTSMedia Articles Related to Clindesse (Clindamycin Vaginal)
Bacterial Vaginosis Could Put Pregnancy At Risk If Left Untreated
Source: Fertility News From Medical News Today [2013.04.18]
Women in the UK are more likely to know about intimate beauty treatments than they are about serious health issues that could make them six times more likely to miscarry or give birth prematurely...
Bacterial Vaginosis Increases Female-to-Male HIV Transmission Risk
Source: MedicineNet Bacterial Vaginosis Specialty [2012.06.27]
Title: Bacterial Vaginosis Increases Female-to-Male HIV Transmission Risk
Category: Health News
Created: 6/26/2012 6:06:00 PM
Last Editorial Review: 6/27/2012 12:00:00 AM
Bacterial Vaginosis
Source: MedicineNet Chlamydia In Women Specialty [2012.05.16]
Title: Bacterial Vaginosis
Category: Diseases and Conditions
Created: 11/7/2001 1:44:00 PM
Last Editorial Review: 5/16/2012 12:00:00 AM
What is Bacterial Vaginosis?
Source: MedicineNet metronidazole cream Specialty [2011.09.19]
Title: What is Bacterial Vaginosis?
Category: Doctor's Views
Created: 5/2/2005 12:00:00 AM
Last Editorial Review: 9/19/2011 12:00:00 AM
Gardnerella Vaginalis May Contribute To Premature Births, STDs
Source: Sexual Health / STDs News From Medical News Today [2013.04.25]
New research at Washington University School of Medicine in St. Louis points to a common species of bacteria as an important contributor to bacterial vaginosis, a condition linked to preterm birth and increased risk of sexually transmitted diseases. The condition affects one in every three women, making it more common than yeast infections...
Published Studies Related to Clindesse (Clindamycin Vaginal)
[Evaluation of efficacy of ketoconazole 800 mg-clindamycin 100 mg tablets vaginal against ketoconazole 800 mg- clindamycin 100 mg vaginal capsules in candida vaginitis and vaginosis]. [2011.02]
CONCLUSIONS: Treatment of vaginitis/vaginosis with vaginal tablets is clinically better than vaginal soft gelatin capsules both treatments were well tolerated.
Efficacy and tolerability of a fixed combination of clindamycin phosphate (1.2%) and low concentration benzoyl peroxide (2.5%) aqueous gel in moderate or severe acne subpopulations. [2009.08]
BACKGROUND: Oral antibiotics are commonly prescribed for moderate or severe acne, but there may be limitations due to concerns about side effects associated with systemic treatments. OBJECTIVE: To evaluate the efficacy and safety of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BP 2.5%) aqueous gel in the treatment of moderate or severe acne subpopulations... CONCLUSION: Clindamycin-BP 2.5% aqueous gel is an effective and safe once-daily treatment for moderate or severe acne.
Clindamycin lotion alone versus combination lotion of clindamycin phosphate plus tretinoin versus combination lotion of clindamycin phosphate plus salicylic acid in the topical treatment of mild to moderate acne vulgaris: a randomized control trial. [2009.05]
BACKGROUND: Acne vulgaris is a common skin disease that affects 85% to 100% of people at some time during their lives. It is characterized by noninflammatory follicular papules or comedones and by inflammatory papules, pustules, and nodules in its more severe forms. AIMS: To compare the efficacy of combination treatment of clindamycin+salicylic acid, versus clindamycin+tretinoin versus clindamycin alone in the treatment of the mild-to-moderate acne vulgaris... CONCLUSIONS: Our data suggested that the efficacy of CS lotion was significantly more than C lotion with respect to the TLC and ASI, although there was no significant difference between CS and CT lotion.
An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% for the once-daily treatment of moderate to severe acne vulgaris: assessment of efficacy and safety in 2813 patients. [2008.11]
OBJECTIVE: We sought to evaluate efficacy, safety, and tolerability of a combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BPO 2.5%) aqueous gel in moderate to severe acne vulgaris... CONCLUSIONS: Clindamycin-BPO 2.5% provides statistically significant greater efficacy than individual active ingredients and vehicle with a highly favorable safety and tolerability profile.
Human lactobacilli as supplementation of clindamycin to patients with bacterial vaginosis reduce the recurrence rate; a 6-month, double-blind, randomized, placebo-controlled study. [2008.01.15]
BACKGROUND: The primary objective of this study was to investigate if supplementary lactobacilli treatment could improve the initial cure rate after vaginal clindamycin therapy, and secondly, if lactobacilli as repeated adjunct treatment during 3 menstrual cycles could lengthen the time to relapse after initial cure... CONCLUSION: The study shows that supplementary treatment combining two different strains of probiotic lactobacilli does not improve the efficacy of BV therapy during the first month of treatment, but for women initially cured, adjunct treatment of lactobacilli during 3 menstrual cycles lengthens the time to relapse significantly in that more women remained BV free at the end of the 6-month follow up. TRIAL REGISTRATION NUMBER: ISRCTN62879834.
Clinical Trials Related to Clindesse (Clindamycin Vaginal)
A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne [Recruiting]
There are many different factors that cause acne. So combination treatment using different
medications that can address these different factors is commonly used to treat acne.
Fixed-dose combination clindamycin phosphate 1. 2% and tretinoin 0. 025% gel and benzoyl
peroxide 6% foaming cloths are both used to treat acne. This study will evaluate the use of
the medications when used together.
Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria [Not yet recruiting]
Few efficient drugs for malaria treatment are available so far. Due to increased exposure of
these drugs and due to the high risk of development of drug resistant strains of Plasmodium
falciparum, new drug combinations have to be actively investigated. The investigators will
test the efficiency, safety and tolerance of combined fosmidomycin and clindamycin treatment
in acute uncomplicated malaria in children aged 3-10 years.
Fosmidomycin With Clindamycin or With Clindamycin Plus Artesunate [Not yet recruiting]
The aim of this study is to evaluate the role of clindamycin and artesunate as possible
combination partners for fosmidomycin to protect it from its susceptibility to recrudescent
infections when used as monotherapy for acute Plasmodium falciparum malaria while retaining
its excellent safety profile
Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea [Recruiting]
The purpose of this study is to determine whether Clindamycin Phosphate 1. 2% And Tretinoin
0. 025% Gel are effective and safe in the treatment of papulopustular rosacea.
Study Evaluating Tigecycline Versus Clindamycin Or Vancomycin On Complicated Skin And Skin Structure Infections Including Those Due To Methicillin-Resistant Staphylococcus Aureus (MRSA) In Pediatric Subjects [Not yet recruiting]
The main purpose of this study is to compare the safety and efficacy of tigecycline versus
clindamycin (including subjects treated with vancomycin) in pediatric subjects (aged 8 to 17
years) with complicated skin and skin structure infections (cSSSI), including those caused
by methicillin-resistant staphylococcus aureus (MRSA).
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