SUMMARY
Cleocin® Vaginal Ovules
(clindamycin phosphate vaginal suppositories)
Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.
CLEOCIN Vaginal Ovules are semisolid, white to off-white suppositories for intravaginal administration. Each 2.5 g suppository contains clindamycin phosphate equivalent to 100 mg clindamycin in a base consisting of a mixture of glycerides of saturated fatty acids.
CLEOCIN Vaginal Ovules are indicated for 3-day treatment of bacterial vaginosis in non-pregnant women. There are no adequate and well-controlled studies of CLEOCIN Vaginal Ovules 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, eg, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, and herpes simplex virus, should be ruled out.
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NEWS HIGHLIGHTS
Published Studies Related to Cleocin Vaginal (Clindamycin Vaginal)
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.
The efficacy and safety of a single dose of polyhexamethylene biguanide gynaecologic solution versus a seven-dose regimen of vaginal clindamycin cream in patients with bacterial vaginosis. [2008.01]
OBJECTIVE: At the present the clinical treatment of choice of bacterial vaginosis (BV) is the use of systemic or local metronidazole or clindamycin. Aim of the study was to evaluate the efficacy and tolerability of a single dose of gynaecologic solution, Polyhexamethylene Biguanide (PHMB), Monogin, in the treatment of BV in comparison to a 7-days treatment with clindamycin vaginal cream... CONCLUSIONS: A single dose, of PHMB gynaecologic solution (Monogin) is equivalent in safety and efficacy to a 7-dose regimen of Clindamycin vaginal cream in the treatment of bacterial vaginosis. Futhermore the compliance as been reported to be higher for the single-dose treatment with PHMB than with 7-days treatment with Clindamycin.
The effects of intravaginal clindamycin and metronidazole therapy on vaginal mobiluncus morphotypes in patients with bacterial vaginosis. [2007.04]
OBJECTIVE: The objective of this study was to compare the effects of treatments for bacterial vaginosis (BV) on vaginal Mobiluncus morphotypes... CONCLUSION: Clindamycin reduces vaginal Mobiluncus morphotypes to a greater extent than metronidazole in patients with BV; this correlates with a higher BV cure rate.
Late miscarriage and preterm birth after treatment with clindamycin: a randomised consent design study according to Zelen. [2006.06]
OBJECTIVE: To screen for bacterial vaginosis (BV) and to investigate the effect of treatment with vaginal clindamycin in order to observe the effect on late miscarriage and delivery prior to 37 completed weeks (primary outcome). DESIGN: Randomised consent design for clinical trials according to Zelen. SETTING: Southeast region of Sweden. POPULATION: A total of 9025 women were screened in early pregnancy... CONCLUSIONS: Clindamycin vaginal cream therapy was associated with significantly prolonged gestation and reduced cost of neonatal care in women with BV. Early screening for BV and treatment with clindamycin saved approximately 27 euro per woman.
Oral clindamycin and histologic chorioamnionitis in women with abnormal vaginal flora. [2006.04]
OBJECTIVE: Oral clindamycin reduced late miscarriage and preterm birth in asymptomatic women with bacterial vaginosis or intermediate flora. We investigated whether clindamycin reduced the incidence of histologic chorioamnionitis as a mechanism for these beneficial effects... CONCLUSION: Although oral clindamycin reduced late miscarriage and preterm birth in women with abnormal vaginal flora, this effect is unlikely to be mediated through a reduction in the incidence of histologic chorioamnionitis. The relatively small size of the groups, however, does not allow us to rule out a real effect, especially given the lower rate of membrane inflammation observed in the clindamycin group. LEVEL OF EVIDENCE: I.
Clinical Trials Related to Cleocin Vaginal (Clindamycin Vaginal)
Dalacin-T Gel Post Approval Study [Completed]
A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS [Completed]
To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine
and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients
with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most
frequent cause of focal central nervous system infection in patients with AIDS. If untreated,
the encephalitis is fatal. At present, it is standard practice to give a combination of
pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of
sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of
therapy difficult. There is some information that high doses of parenteral (such as by
injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus
sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients
with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however,
is costly, requires hospitalization, and is inconvenient for the patient. There is some
indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral
clindamycin may be effective. Leucovorin calcium is useful in preventing
pyrimethamine-associated bone marrow toxicity.
The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis Carinii Pneumonia in Patients With AIDS [Completed]
Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne [Recruiting]
Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative
for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a
combination product including these actives for the treatment of acne vulgaris.
You may be suitable to take part in this study because you have acne vulgaris on your face.
Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms,
legs, and back.
Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin [Completed]
Some antibiotics are also effective against malaria parasites. Fosmidomycin is an antibiotic
that has been shown to be effective against malaria, although it cannot achieve a total cure
in all patients. A previous small study has shown that in combination with clindamycin, an
commonly used antibiotic, it is highly effective and safe, in asymptomatic carriers of
malaria parasites. The current study will evaluate the efficacy and safety of the combination
given for three days in children with uncomplicated malaria in Gabon.
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Page last updated: 2008-06-22
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