Mupirocin Cream Is as Effective as Oral Cephalexin in the Treatment of Secondarily Infected Wounds

Journal of Family Practice, Dec, 1998 by Stephen J. Kraus, Lawrence J. Eron, Gerald W. Bottenfield, Margaret A. Drehobl, William D. Bushnell, Michael A. Cupo

Safety was determined for all randomized patients by interview at each visit. All adverse experiences were judged by the investigator to be not related, possibly related, or related to the study drug.

To assess patient acceptance of the 2 methods of treatment, a survey of all patients was conducted at the end-of-therapy visit. Two of the survey questions were "Do you prefer oral or topical therapy?" and "Was the cream easy to apply?"

DATA ANALYSIS

Each study was designed to enroll at least 150 patients per treatment (300 patients total) to determine with 90% power (beta = .10) that the lower confidence limit of the two-sided 95% CI (alpha = .05) of the difference in the clinical success rates between the 2 treatment groups was not below -10%, assuming that the clinical response rate in the 2 groups was 93%.

Continuous data were analyzed by t test, whereas categorical data were analyzed with the chi-square test. The equivalence of the 2 treatment groups was also assessed by determining the two-tailed 95% CIs of the difference in the proportions of patients with clinical and bacteriologic successes. The treatment groups were considered equally effective if the lower 95% confidence limit was not below -10%. Data were analyzed for the population that completed the study according to protocol, as well as the intention-to-treat population.

RESULTS

The 53 investigational sites were randomly assigned to either of the 2 studies. As a consequence, the 2 studies enrolled very similar populations. The results between the studies were consistent for clinical and bacteriologic efficacy as well as for safety.

Seven hundred six patients were randomized to receive study medication: 357 to receive mupirocin cream and 349 to receive cephalexin (Table 1). A total of 630 patients (89%) completed all 3 visits, and 478 (68%) were considered evaluable for clinical efficacy at the follow-up visit. Individual centers completed from 1 to 57 patients. Seventy-six patients were withdrawn because of adverse experiences, lack of efficacy, deviation from the protocol, or being lost to follow-up (Table 1).

TABLE 1

Patient Data for Those Randomized to Mupirocin Cream Topically or Cephalexin Orally (N = 760)

                                           Mupirocin
                                            Cream

Patients randomized                          357
Patients completing study                    317
Patients clinically evaluable                245
Patients withdrawn                            40
Reasons for withdrawal before
 completion
  Adverse experiences                         10
  Lack of efficacy                             6
  Deviation from protocol                      8
  Lost to follow-up                            9
  Other                                        7
Protocol violations in randomized
 patients                                     112
  Age, years
  Mean [  or -] SD                     36.7 [  or -] 21.1
  Range                                 0.04 - 88.8
Sex (men/women)                             122/123
Race
  White                                       199
  Black                                        17
  Asian                                         5
  Other                                        24
Duration of therapy (days)
  Mean [  or -] SD                      9.6 [  or -] 1.6
Skin Infection Rating Scale score
  Mean [  or -] SD                     16.2 [  or -] 5.2
  Range                                      8 - 34
Patients with diabetes
  (randomized patients)                        19

                                           Cephalexin          P

Patients randomized                           349
Patients completing study                     313
Patients clinically evaluable                 233
Patients withdrawn                             36
Reasons for withdrawal before
 completion
  Adverse experiences                           7
  Lack of efficacy                              7
  Deviation from protocol                      10
  Lost to follow-up                             9
  Other                                         3
Protocol violations in randomized
 patients                                      116
  Age, years
  Mean [  or -] SD                     33.9 [  or -] 22.2    .40
  Range                                 0.03 - 92.1
Sex (men/women)                             126/107          .35
Race                                                         .37
  White                                       202
  Black                                        9
  Asian                                        4
  Other                                        18
Duration of therapy (days)
  Mean [  or -] SD                      9.7 [  or -] 1.4
Skin Infection Rating Scale score
  Mean [  or -] SD                     16.6 [  or -] 5.2     .34
  Range                                      8 - 39
Patients with diabetes
  (randomized patients)                        21