Clindamycin phosphate is used topically alone or in conjunction with benzoyl peroxide in the treatment of inflammatory acne vulgaris. In weighing the potential benefits of topical clindamycin therapy, the possibility of serious adverse GI effects associated with the drug should be considered. Therapy of acne vulgaris must be individualized and frequently modified depending on the types of acne lesions which predominate and the response to therapy. Topical anti-infectives, including clindamycin, generally are effective in the treatment of mild to moderate inflammatory acne. However, use of topical anti-infectives as monotherapy may lead to bacterial resistance; this resistance is associated with decreased clinical efficacy.Topical clindamycin is particularly useful when used with benzoyl peroxide or topical retinoids. Results of clinical studies indicate that combination therapy results in a reduction in total lesion counts of 50-70%.
Clindamycin is used intravaginally as a vaginal cream or suppository or orally for the treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).
Bacterial vaginosis is a noninflammatory vaginal syndrome characterized by replacement of the normal vaginal flora (predominantly hydrogen peroxide-producing Lactobacillus) with a mixed flora including Gardnerella vaginalis, anaerobes (e.g., Bacteroides ureolyticus, Prevotella, Porphyromonas, Peptostreptococcus, Mobiluncus), and Mycoplasma hominis; vaginal discharge may be an unreliable indicator of infection since many women are asymptomatic. While Gardnerella previously was thought to be the sole causative agent of this syndrome, it currently is thought that bacterial vaginosis is a polymicrobial condition in which Gardnerella acts synergistically with anaerobic bacteria and genital mycoplasmas. Clinical diagnosis of the syndrome generally is established by characteristic vaginal manifestations rather than bacteriologic determinations. The presence of at least 3 of the following manifestations is considered diagnostic for bacterial vaginosis: a nonirritating, odoriferous, thin, homogeneous, grayish-white, noninflammatory vaginal discharge that smoothly coats the vaginal walls; a vaginal pH exceeding 4.5; the elaboration of malodorous amines (''fishy'' odor) from discharge fluid after alkalinization with potassium hydroxide 10% (''whiff test''); and/or microscopic smears containing small coccobacillary organisms adherent to epithelial cells (''clue cells''). The presence of clue cells on wet mount examination of vaginal secretions is one of the most reliable indicators of bacterial vaginosis.
Gram stain results consistent with a diagnosis of bacterial vaginosis include markedly reduced or absent Lactobacillus morphology and predominance of Gardnerella morphotype. Although Gram stain of vaginal secretions also has been employed as a diagnostic test for bacterial vaginosis, accuracy of this method depends on evaluation by an experienced microbiologist; thus, this technique is used more often in research and hospital settings whereas diagnosis by clinical criteria typically is performed in an office setting. Gardnerella can be isolated from vaginal cultures in a large proportion of healthy women; because of this lack of specificity, culture for the organism is not recommended as a diagnostic method for bacterial vaginosis, and it is not used to guide therapy. The possibility of other pathogens commonly associated with vulvovaginitis or cervicitis (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, herpes simplex viruses) generally should be ruled out, particularly since coinfection with these organisms may occur.
Goals of treatment and recommended therapy for bacterial vaginosis differ for nonpregnant versus pregnant women. However, relief of signs and symptoms of infection is a principal goal of therapy, and all women with symptomatic bacterial vaginosis should be treated regardless of pregnancy status.
The principal goal in the treatment of bacterial vaginosis in nonpregnant women is to provide relief of vaginal manifestations and signs of infection. Other potential benefits include a reduction in other infectious complications, including human immunodeficiency virus (HIV) infection or other sexually transmitted diseases. The US Centers for Disease Control and Prevention (CDC) states that treatment of bacterial vaginosis is indicated in all nonpregnant women who are symptomatic. The regimens recommended by the CDC for the treatment of bacterial vaginosis in nonpregnant women are a 7-day regimen of oral metronidazole (500 mg twice daily), a 5-day regimen of intravaginal metronidazole gel, or a 7-day regimen of intravaginal clindamycin cream. Alternative regimens recommended by the CDC for these women are a 7-day regimen of oral clindamycin or a 3-day regimen of intravaginal clindamycin suppositories. or
Intravaginal metronidazole therapy results in clinical cure rates comparable to those reported with a 7-day oral metronidazole regimen; intravaginal clindamycin cream appears to be less effective than the metronidazole regimens. The CDC suggests that intravaginal clindamycin is the preferred regimen for the treatment of bacterial vaginosis in women hypersensitive to metronidazole. Regardless of the therapy chosen, relapse or recurrence of bacterial vaginosis is common, and some clinicians suggest that an alternative regimen (e.g., oral therapy when intravaginal therapy was used initially) can be employed in such infections. Long-term maintenance therapy does not appear to be beneficial in women with recurrent or relapsing disease and is not recommended.
Results of several controlled studies indicate that intravaginal clindamycin cream (3- or 7-day regimen) is more effective than placebo for the treatment of bacterial vaginosis. Results of some randomized, double-blind studies for the treatment of symptomatic bacterial vaginosis indicate that 5 g of clindamycin phosphate (2% clindamycin) vaginal cream (100 mg of clindamycin) applied daily for 7 days is as effective as oral metronidazole 500 mg twice daily for 7 days. Patients who were treated with this regimen of intravaginal clindamycin cream had cure rates or combined cure and improvement rates of 57-94% at 4-10 days following completion of therapy, and, in one study, a combined cure and improvement rate of 83% was observed at 1 month following completion of therapy in patients receiving intravaginal clindamycin cream compared with 78% in those receiving oral metronidazole; microbiologic response to therapy paralleled clinical response. In a randomized controlled trial, similar cure rates were obtained with intravaginal clindamycin cream (86%), oral metronidazole (84%), or intravaginal metronidazole gel (75%) at 7-14 days following completion of therapy; interpretation of these results is limited by the statistical limitations of this study (i.e., small sample size, inadequate power, short-term follow-up), and further study is needed to fully establish the comparative efficacy of these treatments. Results of randomized clinical studies indicate that cure rates obtained following a 3-day regimen of clindamycin vaginal suppositories are superior to placebo and comparable to those obtained with a 7-day regimen of oral metronidazole. Results of other studies indicate that cure rates obtained with a single 5-g dose of clindamycin phosphate vaginal cream (Clindesse) are superior to placebo and comparable to those obtained with a 7-day regimen of clindamycin vaginal cream (Cleocin). Long-term follow-up of patients suggests high recurrence rates for bacterial vaginosis regardless of initial therapy.
An increased risk of obstetric complications, including intraamniotic infection, chorioamnionitis, premature rupture of membranes, preterm delivery, and low-birthweight infants, is associated with the presence of bacterial vaginosis in pregnant women, and the organisms found in increased concentrations in the genital flora of women with bacterial vaginosis are frequently found in patients with postpartum or postcesarean endometritis. Evidence from randomized, controlled trials indicates that systemic treatment of bacterial vaginosis reduces the rate of preterm birth in pregnant women at high risk for complications of pregnancy.
Because of the increased risk of adverse pregnancy outcomes associated with the presence of bacterial vaginosis, the CDC recommends that all symptomatic pregnant women be tested and treated for bacterial vaginosis. In addition, because there is evidence from randomized studies that treatment of bacterial vaginosis in asymptomatic pregnant women at high risk for complications of pregnancy (e.g., those who previously delivered a premature infant) has reduced preterm delivery, some experts recommend that all women at high risk be screened and treated for bacterial vaginosis. The CDC recommends that screening for bacterial vaginosis (if conducted) should be performed at the first prenatal visit and treatment initiated if needed. for a complete discussion of screening and treatment for bacterial vaginosis in pregnant women.)
The preferred regimens for the treatment of symptomatic bacterial vaginosis in pregnant women and for the treatment of asymptomatic women at high risk for complications of pregnancy are a 7-day regimen of oral metronidazole (500 mg twice daily or 250 mg 3 times daily) or a 7-day regimen of oral clindamycin (300 mg twice daily). and see Although some experts state that intravaginal therapy may be used solely for symptomatic relief (and not for prevention of adverse pregnancy outcomes) in women at low risk for preterm delivery, others prefer use of systemic therapy for all pregnant women, regardless of degree of risk for complications of pregnancy, because systemic treatment may be required to eradicate upper genital tract infection that may be associated with bacterial vaginosis. Use of intravaginal clindamycin to reduce preterm birth and treat bacterial vaginosis in pregnant women has been evaluated in several studies. In one study in women treated with intravaginal clindamycin early in the pregnancy (i.e., before 20 weeks' gestation), administration of clindamycin was associated with a reduction in preterm birth. In other studies, such therapy administered at 16-32 weeks' gestation did not reduce the incidence of adverse pregnancy outcomes. Therefore, the CDC states that intravaginal clindamycin should only be used during the first half of pregnancy.
Women Undergoing Gynecologic Procedures and Surgery
The goal of treatment of symptomatic bacterial vaginosis in women undergoing hysterectomy or abortion is to reduce the risk of infectious complications (e.g., pelvic inflammatory disease [PID]) following these procedures.
Treatment of asymptomatic bacterial vaginosis in patients who are about to undergo an invasive gynecologic procedure (e.g., endometrial biopsy, hysteroscopy, hysterosalpingography, hysterectomy, placement of an intrauterine device, uterine curettage), abortion, vaginal surgery, or abdominal surgery may be a reasonable consideration because of the association between this condition and various gynecologic infections (e.g., endometritis, PID, vaginal cuff cellulitis). While a reduction in postoperative PID in women with bacterial vaginosis undergoing first-trimester elective abortion has been established in at least one study employing oral metronidazole, further study is needed to determine the value of treating asymptomatic bacterial vaginosis in patients who are about to undergo other invasive procedures.
Recommendations for treatment and preferred regimens for bacterial vaginosis in patients with concurrent HIV infection are the same as those for patients without HIV infection.
Results of several randomized, double-blind, placebo-controlled trials indicate that concurrent treatment of male sexual contacts of a woman with symptomatic bacterial vaginosis generally does not appear to affect the clinical cure rate, including the risk of relapse or recurrence of the syndrome in the woman. Therefore, routine treatment of male sexual contacts currently is not recommended. However, despite the lack of controlled studies showing any benefit, some clinicians believe that treatment of male sexual contacts (with oral metronidazole) of women who have relapsing or recurrent bacterial vaginosis may be reasonable. Further study is needed to elucidate the possible role, if any, of sexual transmission in bacterial vaginosis.
For use of oral or parenteral clindamycin in the treatment or prevention of systemic infections,